Chapter 1 Specifications (DR) : Edition: 164

Edition: 164
Chapter 1 Specifications [DR]
1.1 Name & Model ................................................................................................................................ 1

1.1.1 Common Name .............................................................................................................. 1
1.1.2 Brand Name ................................................................................................................... 1
1.1.3 Model.............................................................................................................................. 1
1.2 Definitions ....................................................................................................................................... 1
1.3 Configurations and System Extendability ....................................................................................... 2

1.3.1 Analyzer Configurations ................................................................................................. 2
1.3.2 Reagent Configurations.................................................................................................. 3
1.3.3 Control Blood and Calibrator .......................................................................................... 3
1.3.4 Others............................................................................................................................. 3
1.4 Interface with Other Instruments..................................................................................................... 4

1.4.1 Analyzers........................................................................................................................ 4
1.4.2 Pneumatic Unit ............................................................................................................... 5
1.4.3 IPU ................................................................................................................................. 5
1.5 System Extendability (Peripherals) ................................................................................................. 6

1.5.1 Options ........................................................................................................................... 6
1.6 System Extendability (Software) ..................................................................................................... 6

1.6.1 System Variations .......................................................................................................... 6
1.6.2 Security soft (Option)...................................................................................................... 6
1.7 Intended Use .................................................................................................................................. 6

1.7.1 Intended Use .................................................................................................................. 6
1.7.2 Average Number of Analysis.......................................................................................... 6
1.7.3 Special Mode Specifications .......................................................................................... 6
1.8 Analysis Principle............................................................................................................................ 7

1.8.1 Blood Volumetric Method ............................................................................................... 7
1.8.2 WBC/NRBC/BASO Analysis .......................................................................................... 7
1.8.3 DIFF Analysis ................................................................................................................. 7
1.8.4 WPC/HPC Detection ...................................................................................................... 7
1.8.5 RET/PLT-O Analysis ...................................................................................................... 7
1.8.6 RBC/ PLT-I Analysis....................................................................................................... 7
1.8.7 HGB Analysis ................................................................................................................. 7
1.8.8 PLT-F Analysis ............................................................................................................... 7
1.9 Analysis Parameters ....................................................................................................................... 8

1.9.1 Analysis Mode and Required Sample Volume ............................................................... 8
1.9.2 Analysis Discrete Mode and Analysis Channels ............................................................ 9
1.9.3 Analysis Discrete Mode & Analysis Channels.............................................................. 13
1.10 Analysis & Display Ranges........................................................................................................... 13
1.11 Reproducibility .............................................................................................................................. 13
1.12 Accuracy ....................................................................................................................................... 13

1.12.1 Blood Cell Count (WBC, RBC) ..................................................................................... 13
1.12.2 Hemoglobin (HGB) ....................................................................................................... 13
1.12.3 Hematocrit (HCT) ......................................................................................................... 13
XN-1000/1500/2000 S/M October 2018

Edition: 164
1.12.4 Blood Cell Classifications (NEUT%, LYMPH%, MONO%, EO%,

BASO%, IG%, NRBC).................................................................................................. 14
1.12.5 Reticulocyte Parameters (RET#, RET%, LFR, MFR, HFR, IRF, RET-He,
RBC-He, Delta-He)....................................................................................................... 14
1.12.6 Platelet Parameters (PLT, IPF%) ................................................................................. 14
1.12.7 Body Fluid Parameters (WBC-BF, RBC-BF, TC-BF#) ................................................. 14
1.12.8 Body Fluid Parameters (MN%, PMN%, MN#, PMN#).................................................. 14
1.12.9 HPC (HPC#)................................................................................................................. 14
1.13 Linearity ........................................................................................................................................ 14
1.14 Carryover ...................................................................................................................................... 15
1.15 Stability ......................................................................................................................................... 15

1.15.1 Temperature Stability ................................................................................................... 15
1.15.2 Overtime stability (Diurnal variation) ............................................................................ 15
1.15.3 Daily stability (Day-to-day variation)............................................................................. 15
1.15.4 Voltage Stability............................................................................................................ 15
1.15.5 Temperature cycle test................................................................................................. 15
1.15.6 Overtime stability after Collecting Blood....................................................................... 15
1.16 Throughput ................................................................................................................................... 16

1.16.1 Whole Blood (WB) Mode
(Sampler Analysis, Manual Analysis, Micro Determination Analysis) .......................... 16
1.16.2 Dilution Mode ............................................................................................................... 16
1.16.3 BF Mode....................................................................................................................... 16
1.16.4 HPC Mode.................................................................................................................... 16
1.17 Reagent Consumption .................................................................................................................. 17
1.18 Traceability ................................................................................................................................... 18
1.19 Noise............................................................................................................................................. 18
1.20 Dimension and Weight.................................................................................................................. 18
1.21 Environmental Requirements ....................................................................................................... 18
1.22 Power Supply................................................................................................................................ 19
1.23 Safety Protection .......................................................................................................................... 19
1.24 Containers for Sample .................................................................................................................. 19

1.24.1 Sample Tube (normal).................................................................................................. 19
1.24.2 Micro Tube ................................................................................................................... 19
1.24.3 Raised Bottom Tube..................................................................................................... 19
1.25 Analysis ........................................................................................................................................ 19
1.26 Rinse Sequence ........................................................................................................................... 20
1.27 Designed Life Time ....................................................................................................................... 20
1.28 Periodical Replacement ................................................................................................................ 20

1.28.1 Maintenance Items ....................................................................................................... 20
1.28.2 Periodical Maintenance Items ...................................................................................... 21
1.29 Conditions of Storing .................................................................................................................... 21
XN-1000/1500/2000 S/M October 2018

Edition: 164
1.30 System Extendability (Software) ................................................................................................... 22
1.31 XN-10/XN-20/XN-11/XN-21 Special Analysis Mode ..................................................................... 30

1.31.1 Special Analysis Mode ................................................................................................. 30
1.31.2 Definitions..................................................................................................................... 30
1.31.3 Special Analysis Mode Configurations ......................................................................... 30
1.31.4 Body Fluid (BF) Mode .................................................................................................. 31
1.31.5 HPC Mode.................................................................................................................... 34
1.31.6 hsA Mode ..................................................................................................................... 37
XN-1000/1500/2000 S/M October 2018

Chapter 1 Specifications [DR]
1.1 Name & Model
1.1.1 Common Name

XN series
1.1.2 Brand Name

Automated Hematology Analyzer XN series
1.1.3 Model
XN-10/ XN-20
XN-11/ XN-21 (North America only)
1.2 Definitions
Analyzers (XN-10/XN-20, XN-11/XN-21) Module for analyzing samples
IPU The computer for controlling each analyzers and
managing data
Samplers Module for moving racks to each analyzer
Single Model Sampler (SA-10) A sampler with reanalysis functions which can connect 1
analyzer
Twin Model Sampler (SA-20) A sampler with reanalysis functions which can connect 2
analyzers
Simplified Sampler (SA-01) A sampler without reanalysis functions which can connect
1 analyzer
Single Model (XN-1000) 1 analyzer with a sampler
Twin Model (XN-2000) 2 analyzers with a sampler
[DR] 2018149
XN-1000/1500/2000 S/M 1-1 October 2018

1.3 Configurations and System Extendability
1.3.1 Analyzer Configurations

(1) There are 2 types of analyzers by hardware difference. A combination for each type of
analyzers and parameters are shown in the following table. Some part of analysis
parameters can be selected by parameters license.
XN-20 XN-10
XN-20[A1] XN-20[A2] XN-10[B1] XN-10[B2] XN-10[B3] XN-10[B4]
WNR      
RBC/PLT      
Parameters
HGB      
WDF      
WPC   - - - -
RET   ON OFF ON OFF
PLT-O ∆  ∆ OFF  OFF
PLT-F ON OFF ON ON OFF OFF
WB, PD, LW      
Analysis
BF Select Select Select Select Select Select

HPC Select Select - - - -
hsA Select Select Select - Select -
XN-21 XN-11
XN-21[A1] XN-21[A2] XN-11[B1] XN-11[B2] XN-11[B3] XN-11[B4]
WNR      
RBC/PLT      
Parameters
HGB      
WDF      
WPC   - - - -
RET   ON OFF ON OFF
PLT-O ∆  ∆ OFF  OFF
PLT-F ON OFF ON ON OFF OFF
     
WB, PD, LW
Anal
Select Select Select Select Select Select

HPC Select Select - - - -
: Equipped ∆: Output as a research
ON: “Selected” by software
OFF: “Not Selected” by software
Select: Selective method by software
* Abbreviation words are as shown in the following table.
WB Whole Blood
PD Pre diluted
LW Low WBC
BF Body Fluid
HPC Hematopoietic Progenitor Cell
hsA High Sensitivity Analysi
XN-1000/1500/2000 S/M 1-2 October 2018

(2) Configuration examples with options
• XN-10/ XN-20
(a) Twin Model (XN-2000)
(Analyzers × 2 + Twin sampler + IPU + Pneumatic Unit)
(b) Single Model (XN-1000) (Successor of XT-4000i)
(Analyzer × 1 + Single Sampler + IPU + Pneumatic Unit)
(c) Simplified Model (Successor of XT-1800i)
(Analyzer × 1 + Simplified Sampler + IPU + Pneumatic Unit)
1.3.2 Reagent Configurations

(1) CELL PACK DCL
(2) SULFOLYSER
(3) LYSERCELL WNR
(4) FLUOROCELL WNR
(5) LYSERCELL WDF
(6) FLUOROCELL WDF
(7) LYSERCELL WPC
(8) FLUOROCELL WPC
(9) CELLPACK DFL
(10) FLUOROCELL RET
(11) FLUOROCELL PLT
(12) CELLSHEATH (C) (for XN-21/XN-11 only)
(13) CELLPACK DST (Concentrated)
(14) CELLCLEAN (Sample tube type)
1.3.3 Control Blood and Calibrator

(1) Control Blood: XN CHECK
(2) Control Blood for Body Fluid: XN CHECK BF
(3) Calibrator: XN CAL (Including sensitivity calibration)
(4) Calibrator for PLT-F: XN CAL PF
1.3.4 Others
(1) Linearity Check Samples: RANGE CHECK X III
XN-1000/1500/2000 S/M 1-3 October 2018

1.4 Interface with Other Instruments
Figure 1
1.4.1 Analyzers
(1) USB Controller for IPU Connection × 1
(2) Pneumatic Unit Control Port × 1
(3) AC Power Inlet Port × 1
(4) Waste Tank with Filled-Water Sensor Port × 1
(5) Reagent Chamber Port × 1
(6) Indication Light Port × 1
XN-1000/1500/2000 S/M 1-4 October 2018

1.4.2 Pneumatic Unit
(1) Control Port × 1
(2) AC Power Inlet Port × 1
1.4.3 IPU
The IPU specifications are as follows.
Operating System (OS) Windows 7 professional (32bit) English version.

Windows 10 IoT Enterprise 2016 LTSB (64bit) English version.
CPU 2.0GHz or higher. Must be a Dual Core.
Memory 4 GB
Hard Disk 160GB or higher.
A Chassis supports 2 bays for RAID.
Chip Set High Precision Evet Timer (HPET) function is needed.
Software RAID
ACPI2.0 for supporting WOL (Supporting suspend power control
S1 state and S3 state).
BIOS USB power supply should be stopped by PC shut down, or having
its setting.
Display 1920 × 1080 Wide Display with a speaker.
Touch Panel Option
Key Board / Mouse One for each is required. USB type or PS2 type can be used.
USB Controller 2 controllers are needed for connecting an analyzer and other
equipment (handheld barcode reader, printer, keyboard and
mouse).
4 ports or more are needed.
USB hub can be used. However, USB hub should operate by bus
power on PC for connecting an analyzer (do not use self-power). It
is necessary for starting an analyzer from PC.
Parallel Port Use only for a data printer.
Serial Port Use only for connection between LIS and RS-232C.
Network Card (NIC) 2 ports are necessary for 100/1000baseT.
For direct connections to LIS, SNCS, remote access and others, or
for hospital management terminals service connections.
For LAS (HST-NEXT, WAM, Reagent supply instrument)
connections. This NIC should have “Wake On Lan” function.
* If the PC is acquired locally, it is possible to use PC with higher interfaces than above, however the
interface with other instruments must be as shown in Figure 1.
XN-1000/1500/2000 S/M 1-5 October 2018

1.5 System Extendability (Peripherals)
1.5.1 Options
(1) Sampler (Including dock space)
(2) Wagon for XN series without a reagent chamber
(3) Wagon for XN series with a reagent chamber
(4) Concentration reagent dilution unit
(5) Touch panel, Monitor arm
(6) Handheld barcode reader
(7) DP Printer
(8) GP /LP Printer
(9) Waste tank with Filled-water detection sensor
(10) Indication light
1.6 System Extendability (Software)
1.6.1 System Variations

Refer to “1.30System Extendability (Software)”
1.6.2 Security soft (Option)

McAfee SECURITY MASTER
1.7 Intended Use
1.7.1 Intended Use

XN series analyze CBC item, DIFF item, RET related items and NRBC item in anticoagulant
for human blood. Anti-coagulant are EDTA-2K, EDTA-3K EDTA-2Na. Volume of anti-
coagulant conform to CLSI. This instrument also analyzes few cells in peripheral blood, or
samples excluding peripheral blood (body fluid, cord blood, Harvest) by special mode.
1.7.2 Average Number of Analysis

200 times a day (per 1 analyzer)
1.7.3 Special Mode Specifications

Refer to “1.31XN-10/XN-20/XN-11/XN-21 Special Analysis Mode”
XN-1000/1500/2000 S/M 1-6 October 2018

1.8 Analysis Principle
1.8.1 Blood Volumetric Method

Pipetting method using a syringe.
1.8.2 WBC/NRBC/BASO Analysis

The diluted samples for analyzing WBC/NRBC/BASO are forced to the center of the sheath
reagent (CELLPACK) flowing in the flowcell by pushing with the volumetric syringe. The
specified volume of samples are analyzed in automatic discrimination to analyze the forward
scatter (FSC) and the side fluorescent light (SFL) by the Flow Cytometry Method with using
the semiconductor laser.
1.8.3 DIFF Analysis

The diluted sample for analyzing DIFF is forced to the center of the sheath reagent
(CELLPACK) flowing in the flowcell by pushing with the volumetric syringe. The specified
volume of samples are analyzed in automatic discrimination to analyze the side scatter
(SSC) and the side fluorescent light (SFL) by the Flow Cytometry Method with using the
semiconductor laser.
1.8.4 WPC/HPC Detection

The diluted samples for analyzing WPC/HPC detection are forced to the center of the sheath
scatter (FSC), side scatter (SSC) and the side fluorescent light (SFL) by the Flow Cytometry
Method with using the semiconductor laser.
1.8.5 RET/PLT-O Analysis

The diluted samples for analyzing RET/PLT-O are forced to the center of the sheath reagent
(CELLPACK) flowing in the flowcell by pushing with the volumetric syringe. The specified
volume of samples are analyzed in automatic discrimination to analyze the forward scatter
(FSC) , the side scatter (SSC) and the side fluorescent light (SFL) by the Flow Cytometry
1.8.6 RBC/ PLT-I Analysis

The diluted samples for analyzing RBC/PLT-I are forced to the center of the sheath reagent
(CELLPACK) by pushing with the volumetric syringe. The specified volume of sample
particles pass through the 75 micrometer diameter pore, and are analyzed by automatic
discrimination by the sheath flow DC method.
1.8.7 HGB Analysis

The abosoption value of the transmitted light in the diluted sample is analyzed in every
analysis. The Hgb value is obtained by subtracting diluent converted value from the Hgb
diluted sample converted value (Colorimetric method).
* Analysis Method: SLS-Hb method.
1.8.8 PLT-F Analysis

The diluted sample for analyzing PLT-F detection is forced to the center of the sheath
scatter (FSC), side scatter (SSC) and the side fluorescent light (SFL) by the Flow Cytometry
XN-1000/1500/2000 S/M 1-7 October 2018

1.9 Analysis Parameters
1.9.1 Analysis Mode and Required Sample Volume

Each Analysis Mode is shown in the following table.
Required
Asp.
Outline Support Blood
Volume
Volume
Basic analysis mode for Sampler Analysis*1  88μL 1mL
analyzing human Sampler Analysis
 88μL 250μL
peripheral blood. (Raised bottom tube analysis)
WB Low WBC mode needs 3- Manual Analysis  88μL 1mL
Mode
times longer counting time Manual Analysis
LW  88μL 250μL
Mode in basic analysis mode (Raised bottom tube analysis)
Micro Analysis*2  88μL 0.3mL
Micro Analysis*3
 88μL 160μL
(Micro tube analysis)
Analysis mode for Sampler Analysis*1 - - -
analyzing the blood sample Sampler Analysis
- - -
diluted with CELLPACK (Raised bottom tube analysis)
(B1) (7-fold dilution) *4 Manual Analysis - - -
Dilution Manual Analysis
(PD) - - -
(Raised bottom tube analysis)
Mode
Micro Analysis*3 140μL
(Micro tube analysis)  70μL (After
dilution)
analyzing WBC and RBC in Sampler Analysis
- - -
the body fluid (Raised bottom tube analysis)
Body Manual Analysis  88μL 1mL
Fluid Manual Analysis
- - -
Mode (Raised bottom tube analysis)
Micro Analysis*3
 88μL 160μL
Analysis mode for very small
cells in peripheral blood, or
Special
samples other than
Analysis Refer to 1.31XN-10/XN-20/XN-11/XN-21 Special Analysis Mode
peripheral blood (body fluids,
Mode
umbilical cord blood,
harvest)
analyzing hematopoietic Manual Analysis  190μL 1mL
HPC
precursor cell number Micro Analysis*2  190μL 0.4mL
Mode
Micro Analysis*3
 190μL 260μL
XN-1000/1500/2000 S/M 1-8 October 2018

: Supported, -: Not Supported
*1 Sampler analysis: Analysis with automatic sample tube transportation by the sampler.
*2 Micro analysis: Manual analysis with the cap-opened sample tube for reducing the dead volume.
*3 Micro analysis (Micro tube analysis): Analysis with a cap-opened micro tube.
*4 Assumed operation is analysis of a sample of 20μL whole blood diluted with 120μL CELLPACK B1 (7-
fold dilution) using a micro tube.
1.9.2 Analysis Discrete Mode and Analysis Channels
(1) Whole Blood (WB) Mode (: Analyzed, - : Not Analyzed)

XN-20[A1], XN-21[A1]
Analysis Channels
RBC/PLT HGB WNR WDF WPC RET PLT-F
1    - - - -
2     - - -
3      - -
4       -
5    - -  -
6     -  -
7    - - - 
8     - - 
9      - 
10       
11    - -  
12     -  
XN-20[A2], XN-21[A2]
Analysis Channels
1    - - - N/A
2     - - N/A
3      - N/A
4       N/A
5    - -  N/A
6     -  N/A
XN-10[B1], XN-11[B1]
Analysis Channels
1    - N/A - -
2     N/A - -
3    - N/A  -
4     N/A  -
5    - N/A - 
6     N/A - 
7    - N/A  
8     N/A  
XN-1000/1500/2000 S/M 1-9 October 2018

XN-10[B2], XN-11[B2]
Analysis Channels
1    - N/A N/A -
2     N/A N/A -
3    - N/A N/A 
4     N/A N/A 
XN-10[B3], XN-11[B3]
Analysis Channels
1    - N/A - N/A
2     N/A - N/A
3    - N/A  N/A
4     N/A  N/A
XN-10[B4], XN-11[B4]
Analysis Channels
1    - N/A N/A N/A
2     N/A N/A N/A
(2) LW Mode (: Analyzed, - : Not Analyzed)

(WDFch of WB mode needs 3-times longer of counting time. WBC is calculated from WDFch)
XN-20[A1], XN-21[A1]
Analysis Channles
1     - - -
2      - -
3       -
4     -  -
5     - - 
6      - 
7       
8     -  
XN-20[A2], XN-21[A2]
Analysis Channels
1     - - N/A
2      - N/A
3       N/A
4     -  N/A
XN-10[B1], XN-11[B1]
Analysis Channels
1     N/A - -
2     N/A  -
3     N/A - 
4     N/A  
XN-1000/1500/2000 S/M 1-10 October 2018

XN-10[B2], XN-11[B2]
Analysis Channles
1     N/A N/A -
2     N/A N/A 
XN-10[B3], XN-11[B3]
Analysis Channles
1     N/A - N/A
2     N/A  N/A
XN-10[B4], XN-11[B4]
Analysis Channels
1     N/A N/A N/A
(3) PD Mode (: Analyzed, - : Not Analyzed)

XN-20[A1], XN-21[A1]
Analysis Channels
1    - - - -
2     - - -
3     -  
XN-20[A2], XN-21[A2]
Analysis Channles
1    - - - N/A
2     - - N/A
3     -  N/A
XN-10[A2], XN-11[A2]
Analysis Channels
1    - N/A - -
2     N/A - -
3     N/A  
XN-10[B2], XN-11[B2]
Analysis Channels
1    - N/A N/A -
2     N/A N/A -
3     N/A N/A 
XN-1000/1500/2000 S/M 1-11 October 2018

XN-10[B3], XN-11[B3]
Analysis Channels
1    - N/A - N/A
2     N/A  N/A
3     N/A  N/A
XN-10[B4], XN-10[B4]
Analysis Channels
1    - N/A N/A N/A
2     N/A N/A N/A
(4) Body Fluid (BF) Mode (: Analyzed, - : Not Analyzed)

All Analyzers (Common)
Analysis Channels
1  - -  - - -
XN-1000/1500/2000 S/M 1-12 October 2018

1.9.3 Analysis Discrete Mode & Analysis Channels
Refer to Appendix 1.
1.10 Analysis & Display Ranges

1.11 Reproducibility
When fresh blood samples (NRBC = Nucleated Red Blood Cell, IG = Immature Granulocyte,
RET-He = more than RET# 2.0 × 104/μL) or control blood are continuously analyzed for more
than 10 times, coefficient of variation should be 95% confidence and as stated in Appendix 1.
However, method for the following parameters and analysis modes are as shown in the table
below.
Parameter /
Method
Analysis Mode
PLT-F Diluted fresh blood or control blood are used as samples.
Low WBC Mode
NRBC%, NRBC# Analyzing abnormal samples of the fresh blood including NRBC and IG
IG%, IG# cells continuously more than 5 times. (Because volume of abnormal
samples is limited)
Body Fluid Mode Analyzing pseudo samples diluted with human blood or control blood
(Body fluid degrade by mixing or over time).
HPC Mode Analyzing HPC existing samples continuously more than 5 times
(Because volume of samples is limited).
1.12 Accuracy
1.12.1 Blood Cell Count (WBC, RBC)

When more than 100 fresh blood samples are analyzed after calibrating the instrument, the
average of these samples comparing to the same samples which run on the XE-5000
standard instrument (or equivalent) or XN-20 standard instrument (or equivalent) should be
in range of Appendix 1.
1.12.2 Hemoglobin (HGB)

standard instrument (or equivalent) or the XN-20 standard instrument (or equivalent) or
“*International Council for Standardization in Hematology” should be in range of Appendix 1.
* Standard Hemoglobin analysis method using Cyanmethemoglobin method (HiCN)
recommended by ICSH (International Council for Standardization in Hematology).
1.12.3 Hematocrit (HCT)

standard instrument (or equivalent), the XN-20 standard instrument (or equivalent) or
“*International Council for Standardization in Hematology” should be in range of Appendix 1.
* Standard analysis method recommended by ICSH (International Council for
Standardization in Hematology).
XN-1000/1500/2000 S/M 1-13 October 2018

1.12.4 Blood Cell Classifications (NEUT%, LYMPH%, MONO%, EO%,
BASO%, IG%, NRBC)
When more than 100 fresh blood samples or more than 20 NRBC, IG are analyzed, the
correlation coefficient analyzed should be in range of Appendix 1. XE-5000 standard
instrument (or equivalent) or XN-20 standard instrument (or equivalent) shall be used for
comparison. Also, the average comparing to the same samples run on the XE-5000 standard
instrument (or equivalent) or the XN-20 standard instrument (or equivalent) should be in
range of Appendix 1.
1.12.5 Reticulocyte Parameters (RET#, RET%, LFR, MFR, HFR, IRF, RET-He,
RBC-He, Delta-He)
When more than 100 fresh blood samples, the correlation coefficient analyzed should be in
range of Appendix 1. XE-5000 standard instrument (or equivalent), XN-20 standard
instrument (or equivalent) or visual method (CLSI H44-A2) shall be used for comparison.
Also, the average comparing to the same samples run on the XN-20 standard instrument (or
equivalent) should be in range of Appendix 1.
1.12.6 Platelet Parameters (PLT, IPF%)

When more than 100 fresh blood samples including more than 20 of 50000/µL or less
platelets samples, or more than 10 of over 10% IPF samples are analyzed, the correlation
coefficient analyzed should be in range of Appendix 1. For PLT, samples run on the FCM
analysis method by ICSH shall be used for comparison. For IPF, XE-5000 standard
instrument (or equivalent) or XN-20 standard instrument (or equivalent) shall be used for
comparison.
* The reference method for platelet counting would be tested using FCM in the ICSH
(International Council for Standardization in Haematology) protocol. Am J Clin Pathol.
2001;1:115: 460-464.
1.12.7 Body Fluid Parameters (WBC-BF, RBC-BF, TC-BF#)

In a correlation test using more than 50 body fluid samples, the slope of the correlation
coefficient (r) and the regression line comparing to the control method (visual method) should
be in range of the Appendix 1.
1.12.8 Body Fluid Parameters (MN%, PMN%, MN#, PMN#)

In a correlation test using more than 50 body fluid samples, the slope of the correlation
coefficient (r) and the regression line comparing to the control method (visually classify the
slides prepared by the cytospin method) should be in range of the Appendix 1.
1.12.9 HPC (HPC#)

When more than 20 peripheral blood samples (HPC existing sample) are analyzed, the
average comparing to the control method using Flow Cytometry Method (CD34 positive cell
analysis) should be in range of Appendix 1.
1.13 Linearity
Residual (ratio) should be in specified concentration range of Appendix 1.
XN-1000/1500/2000 S/M 1-14 October 2018

1.14 Carryover
However, method for the following parameters and analysis modes are as shown in the table below.
Parameter/
Method
Analysis Mode
Body Fluid Mode Evaluate using an artificial sample (adjusted to 100.00 × 102/μL for
WBC-BF, TC-BF and 500.0 × 104/μL for RBC-BF).
* Blank check is required if analysis result for WBC-F, TC-BF# is
higher than 10.00 × 102/μL and RBC-BF is higher than 100.00 ×
104/μL, and the sample to be analyzed next is low value sample.
1.15 Stability
1.15.1 Temperature Stability

Using fresh blood samples or control blood, the fluctuation by the standard analysis method
should be in range of Appendix A. The ranges of temperature change should be 15°C
through 30°C in both of reagents and instruments.
Fresh blood samples should be collected within 12 hours.
The variation of samples should be subtracted from the variation ratio for the RET related
parameter.
1.15.2 Overtime stability (Diurnal variation)

Using control blood, the fluctuation by the standard analysis method should be in range of
Appendix 1.
1.15.3 Daily stability (Day-to-day variation)

Appendix 1.
1.15.4 Voltage Stability

Appendix 1.
1.15.5 Temperature cycle test

Continuously analyze control blood ten times before and after the test to obtain an average
value. The variation (absolute value) for before and after the test based on the pre-test shall
be within the range of Appendix 1.
1.15.6 Overtime stability after Collecting Blood

The variation after collecting *health human fresh blood should be in range of Appendix 1.
* In NRBC and IG, the blood samples which are detected each cell are targeted.
XN-1000/1500/2000 S/M 1-15 October 2018

1.16 Throughput
1.16.1 Whole Blood (WB) Mode

(Sampler Analysis, Manual Analysis, Micro Determination Analysis)
CBC: 100 samples/hr [[81 samples/hr]]
CBC+DIFF: 100 samples/hr [[81 samples/hr]] [88 samples/hr]
CBC+DIFF+WPC: 88 samples/hr [[71 samples/hr]] [68 samples/1hr]
CBC+DIFF+ WPC +RET: 71 samples/hr [[59 samples/hr]] [57 samples/hr]
CBC+RET: 83 samples/hr [[68 samples/hr]]
CBC+DIFF+RET: 83 samples/hr [[68 samples/hr]] [65 samples/hr]
CBC+PLT-F: 68 samples/hr [[57 samples/hr]]
CBC+DIFF+PLT-F: 68 samples/hr [[57 samples/hr]] [55 samples/hr]
CBC+DIFF+ WPC +PLT-F: 53 samples/hr [[47 samples/hr]] [45 samples/hr]
CBC+DIFF+ WPC +RET+PLT-F: 47 samples/hr [[42 samples/hr]] [41 samples/hr]
CBC+RET+PLT-F: 47 samples/hr [[42 samples/hr]]
CBC+DIFF+RET+PLT-F: 47 samples/hr [[42 samples/hr]] [41 samples/hr]
* [[ ]] = Analysis using raised bottom tube
* [ ] = Low WBC counting mode
1.16.2 Dilution Mode

CBC: 90 samples/hr [All types]
CBC+DIFF: 90 samples/hr [All types]
CBC+DIFF+RET: 53 samples/hr [A2, B3]
CBC+DIFF+PLT-F: 52 samples/hr [B2]
CBC+DIFF+RET+PLT-F: 39 samples/hr [A1, B1]
1.16.3 BF Mode
40 samples/hr
1.16.4 HPC Mode

CBC+DIFF+WPC+RET: 18 samples/hr
CBC+DIFF+WPC+RET+PLT-F: 16 samples/hr
XN-1000/1500/2000 S/M 1-16 October 2018

1.17 Reagent Consumption
XN-10/20 Reagent Consumption for WB analysis (Continuous analysis) [Unit: mL]
PLT-
　 SLS WNR WDF WPC RET
F CELL
hemo Stain hemo Stain hemo Stain hemo Stain Stain PACK Total
　 lytic soluti lytic soluti lytic soluti lytic soluti soluti DCL
Discrete Mode agent on agent on agent on agent on on
CBC 0.5 1.5 0.02 0.0 0.00 0.0 0.00 0.0 0.00 0.00 27.9 29.92
CBC+DIFF 0.5 1.5 0.02 1.5 0.02 0.0 0.00 0.0 0.00 0.00 32.8 36.34
CBC+DIFF+WPC 0.5 1.5 0.02 1.5 0.02 1.5 0.02 0.0 0.00 0.00 38.9 43.96
CBC+DIFF+WPC+RET 0.5 2.5 0.02 1.5 0.02 1.5 0.02 1.5 0.02 0.00 45.6 53.18
CBC+RET 0.5 2.5 0.02 0.0 0.00 0.0 0.00 1.5 0.02 0.00 37.5 42.04
CBC+DIFF+RET 0.5 2.5 0.02 1.5 0.02 0.0 0.00 1.5 0.02 0.00 40.1 46.16
CBC+PLT-F 0.5 1.5 0.02 0.0 0.00 0.0 0.00 1.5 0.00 0.02 39.0 42.54
CBC+DIFF+PLT-F 0.5 1.5 0.02 1.5 0.02 0.0 0.00 1.5 0.00 0.02 41.0 46.06
CBC+DIFF+WPC+PLT-F 0.5 1.5 0.02 1.5 0.02 1.5 0.02 1.5 0.00 0.02 47.5 54.08
CBC+DIFF+WPC+RET+
0.5 2.5 0.02 1.5 0.02 1.5 0.02 3.0 0.02 0.02 53.7 62.80
PLT-F
CBC+RET+PLT-F 0.5 2.5 0.02 0.0 0.00 0.0 0.00 3.0 0.02 0.02 47.6 53.66
CBC+DIFF+RET+PLT-F 0.5 2.5 0.02 1.5 0.02 0.0 0.00 3.0 0.02 0.02 50.2 57.78
* CBC includes WNRch counting

XN-11/21 Reagent Consumption for WB analysis (Continuous analysis) [Unit: mL]
PLT-
SLS WNR WDF WPC RET
F CELL CELL
hemo Stain hemo Stain hemo Stain hemo Stain Stain PACK SHEATH Total
lytic soluti lytic soluti lytic soluti lytic soluti soluti DCL C
Discrete Mode agent on agent on agent on agent on on
CBC 0.5 1.5 0.02 0 0 0 0 0 0 0 10.9 17.0 29.92
CBC+DIFF 0.5 1.5 0.02 1.5 0.02 0 0 0 0 0 15.8 17.0 36.34
CBC+DIFF+WPC 0.5 1.5 0.02 1.5 0.02 1.5 0.02 0 0 0 21.9 17.0 43.96
CBC+DIFF+WPC+RET 0.5 2.5 0.02 1.5 0.02 1.5 0.02 1.5 0.02 0 28.6 17.0 53.18
CBC+RET 0.5 2.5 0.02 0 0 0 0 1.5 0.02 0 20.5 17.0 42.04
CBC+DIFF+RET 0.5 2.5 0.02 1.5 0.02 0 0 1.5 0.02 0 23.1 17.0 46.16
CBC+ PLT-F 0.5 1.5 0.02 0 0 0 0 1.5 0 0.02 22.0 17.0 42.54
CBC+DIFF+PLT-F 0.5 1.5 0.02 1.5 0.02 0 0 1.5 0 0.02 24.0 17.0 46.06
WB CBC+DIFF+WPC+PLT-F
0.5 1.5 0.02 1.5 0.02 1.5 0.02 1.5 0 0.02 30.5 17.0 54.08
Mode
CBC+DIFF+WPC+RET+
0.5 2.5 0.02 1.5 0.02 1.5 0.02 3 0.02 0.02 36.7 17.0 62.8
PLT-F
CBC+RET+PLT-F 0.5 2.5 0.02 0 0 0 0 3 0.02 0.02 30.6 17.0 53.66
CBC+DIFF+RET+PLT-F 0.5 2.5 0.02 1.5 0.02 0 0 3 0.02 0.02 33.2 17.0 57.78
CBC+DIFF 0.5 1.5 0.02 1.5 0.02 0 0 0 0 0 20.3 17.0 40.84
CBC+DIFF+WPC 0.5 1.5 0.02 1.5 0.02 1.5 0.02 0 0 0 26.4 17.0 48.46
CBC+DIFF+WPC+RET 0.5 2.5 0.02 1.5 0.02 1.5 0.02 1.5 0.02 0 32.6 17.0 57.18
CBC+DIFF+RET 0.5 2.5 0.02 1.5 0.02 0 0 1.5 0.02 0 26.6 17.0 49.66
LW
CBC+DIFF+PLT-F 0.5 1.5 0.02 1.5 0.02 0 0 1.5 0 0.02 29.0 17.0 51.06
Mode
CBC+DIFF+WPC+PLT-F 0.5 1.5 0.02 1.5 0.02 1.5 0.02 1.5 0 0.02 35.5 17.0 59.08
CBC+DIFF+WPC+RET+
0.5 2.5 0.02 1.5 0.02 1.5 0.02 3 0.02 0.02 41.2 17.0 67.3
PLT-F
CBC+DIFF+RET+PLT-F 0.5 2.5 0.02 1.5 0.02 0 0 3 0.02 0.02 37.7 17.0 62.28
XN-1000/1500/2000 S/M 1-17 October 2018

CBC 0.5 1.5 0.02 0 0 0 0 0 0 0 13.0 16.5 31.52
CBC+DIFF 0.5 1.5 0.02 1.5 0.02 0 0 0 0 0 22.5 16.5 42.54
PD CBC+DIFF+RET+PLT-F 0.5 2.5 0.02 1.5 0.02 0 0 3 0.02 0.02 35.8 16.5 59.88
Mode
CBC+DIFF+RET 0.5 2.5 0.02 1.5 0.02 0 0 1.5 0.02 0 30.7 16.5 53.26
CBC+DIFF+PLT-F 0.5 1.5 0.02 1.5 0.02 0 0 1.5 0 0.02 30.6 16.5 52.16
Body CBC+DIFF
Fluid 0 0 0μL 1.5 0.02 0 0 0 0 0 20.4 21.0 42.92
Mode
CBC+DIFF+RET+HPC 0.5 2.5 0.02 1.5 0.02 4.5 0.08 1.5 0.02 0 55.4 27.5 93.54
HPC
CBC+DIFF+RET+
Mode 0.5 2.5 0.02 1.5 0.02 4.5 0.08 3 0.02 0.02 66.0 27.5 105.66
PLT-F+HPC
* CBC includes WNRch counting
1.18 Traceability
Refer to the Appendix 1.
1.19 Noise
60 dB or lower (with sampler)
Following noises are not included. It should be under 50dB in standby status (pneumatic unit
stops operation)
• Drainage sound of rinse cup
• Feed-in sound or Ejection sound of sample racks
• sound of clamping sample tubes or sound of releasing sample tubes
• Alarm sound
1.20 Dimension and Weight

Dimension and Weight
Dimension (W×D×H (mm)) Weight
Analyzer 300 × 640 × 790 Approx. 49kg
IPU (data operation unit) Depends on the PC spec Depends on the PC spec
Pneumatic Unit 280 × 355 × 400 Approx. 17kg
Single Model 645 × 755 × 855 Approx. 78kg
Twin Model 960 × 880 × 855 Approx. 143 kg
* To differentiate XN-11/XN-21 and XN-10/XN-20, “RLApp” is displayed on the analyzer cover.
1.21 Environmental Requirements

• Ambient and reagent temperatures: 15°C- 30°C
• Relative humidity: 20%- 85%
• Relative pressures: 70kPa- 106kPa
• Installation location: Avoid from direct sunshine, dust, vibration and acid.
XN-1000/1500/2000 S/M 1-18 October 2018

1.22 Power Supply
• Voltage: AC 100V- 240 V
• Frequency: 50Hz/ 60Hz
• Power consumption: see the following table.
Power consumption
Analyzers Pneumatic Unit
100V- 240V 100V- 120V 220V- 240V
50Hz 230 VA or lower 220 VA or lower
270VA or lower
60Hz 280 VA or lower 250 VA or lower
1.23 Safety Protection

Class I Instrument
1.24 Containers for Sample
1.24.1 Sample Tube (normal)

Refer to Instruction for Use.
1.24.2 Micro Tube

1.24.3 Raised Bottom Tube

1.25 Analysis
Modes and Analysis Procedure
Sampler Mode with
Manual Mode
Barcode Reader
WB Mode WB Mode Dilution Mode BF Mode
Sample tube Sample tube (normal)

Sample Sample tube (normal) Sample tube (normal)
(normal) with cap Micro Tube
Tube Micro Tube Micro Tube
Raised bottom tube Raised bottom tube
Materials WB WB × 7 diluted samples Body Fluid
<Analysis Procedure>
1. Switching Select the analysis mode (normal mode, dilution mode, BF mode)
Analysis - after switching to manual mode.
Mode
2. Input Input sample number, discrete and other.
sample - (This procedure can be skipped when sample numbers and discrete
number are read with analyzer internal barcode reader.)
3. Start Set the rack to the Place the samples to the rack and press the start switch.
analyzing sampler
XN-1000/1500/2000 S/M 1-19 October 2018

1.26 Rinse Sequence
• Auto rinse (Background Check)
Analyzing a background check will be extended when values are not in the range of the
following table. Extended cycle is up to 2 times (Maximum cycles for the background check is
3 times). If the value of the background check of last cycle is not in the range of the following
table, background check error occurs.
Background Check Level
Parameter Range
WBC-N 1.0 × 102/µL or lower
WBC-D 1.0 × 102/µL or lower
WBC-P 1.0 × 102/µL or lower
RBC-I 2 × 104/µL or lower
HGB 0.1g/dL or lower
PLT-I 1.0 × 104/µL or lower
PLT-F 0.3 × 104/µL or lower
PLT-O 1.0 × 104/µL or lower
Background Check Level (Body Fluid Mode)
Parameter Range
WBC-BF 0.01 × 102/µL or lower
RBC-BF 0.3 × 104/µL or lower
1.27 Designed Life Time
Useful Life 5 years

Number of standard 200 samples/1 day (per 1 analyzer)
sample processing
Designed Life Time 200 samples per 1 day x 300 days per 1 year x 5 years = 300,000 samples
1.28 Periodical Replacement
1.28.1 Maintenance Items
Description Period Method Operator

Piercer Once per 2 years (120,000 times) Replace FSR
FCM Sheath Syringe Seal Once per 2 years (260,000 times) Replace FSR
WB Syringe Seal Once per 2 years (120,000 times) Replace FSR
RBC Sheath Syringe Seal Once per 2 years (120,000 times) Replace FSR
XN-1000/1500/2000 S/M 1-20 October 2018

1.28.2 Periodical Maintenance Items
Required
Description Period Method Operator
Time
Start up Once a Operating automatically when startup User Approx. 10
day minutes
(When
ambient
temperature
= 23°C)
Shut down Once a Place CELLCLEAN (sample tube type) to the User Approx. 15
day sampler.(By a setting, a rinse sequence is minutes
executed and shut down automatically.)
Rinse Once Perform cleaning from maintenance menu. User Approx. 20
Sequence per Place CELLCLEAN (sample tube type) to the minutes
1000 sampler. (By a setting, a rinse sequence is
analysis executed and returns in ready state
automatically.)
1.29 Conditions of Storing

• Ambient temperature: -10°C- 60°C
• Relative Humidity: 20%- 95%
• Pressure: 70 kPa- 106kPa
XN-1000/1500/2000 S/M 1-21 October 2018

1.30 System Extendability (Software)
The system variations supported by XN series are shown in Table 1. Each system is connected to
one IPU.
Table 1: System Variations
System Variations Description
XE-2100 stand-alone system (Equivalent)
2 Analyzer Modules (3 modules configuration)
Analyzer Analyzer
Module Module
Sampler Module
SA-20
XN-2000 Model
1 Analyzer Module, 1 Hematology Module
(3 modules configuration)
Hematology Analyzer
Module Module
Sampler Module
SA-21
XN-1500 Model
XT-2000i stand-alone system (Equivalent)
1 Analyzer Module (2 modules configuration)
Analyzer
Module
Sampler Module
SA-10
XN-1000 Model
XE-Alpha system (Equivalent)
2 Analyzer Modules (3 modules configuration)
Analyzer Analyzer
ＳＰ
Module Module Supports following two modes.
(1) Host mode
Sampler Module Sampler Module A mode for a facility where the host computer manages all
SA-30 (SP Sampler) SA-30 (XN Sampler)
orders. XN IPU and SP-10/SP-50 are connected to the host
XN-3000/XN-3100 Model computer, respectively, and the host computer issues direct
hematology slide preparation instructions to SP-10/SP-50.
(2) Standalone mode
Only XN IPU connects to host computer, and XN IPU issues
hematology slide preparation instruction to SP-10/SP-50.
Connection model with other company’s CRP device. (For China
market only)
Other company’s Analyzer Analyzer
CRP device Module Module The host computer manages all orders. Supports only the
configuration in which XN IPU and other company's CRP device
Sampler Module are connected to the host computer and the host computer issues
SA-30
analysis instruction to other company's CRP device (the order
XN-2800 Model management method is the same as XN - 3000 Host mode mode).
XN-1000/1500/2000 S/M 1-22 October 2018

System Variations Description
Models which support transportation system.
This system is used with transportation system and information
Analyzer Analyzer Analyzer
Module Module Module system such as WAM, and it is assumed to cover inspection facility
or large scale hospital which process multiple samples.
Sampler Module Sampler Module Sampler Module
ＣＶ-50 ＣＶ-50 ＣＶ-50 There are following two models.
XN-9000 Model (1) XN-9000 model
Combination of 1 Analyzer Module (2 modules configuration).
Capable of connecting 1 Analyzer Module (XN-20, XN-10,
Analyzer Analyzer Analyzer
Module Module Module XN-21, or XN-11) and 1 Sampler Module (CV-50) on maximum
3 XN IPU.
Sampler Module Sampler Module
ＣＶ-50 CV-55 (2) XN-9100 model
XN-9100 Model Combination of 2 Analyzer Modules (3 modules configuration)
and 1 Analyzer Module (2 module configuration).
Capable of connecting 2 Analyzer Modules (XN-20, XN-10,
XN-21, or XN-11) and 1 Sampler Module (CV-55) on 1 XN IPU.
Or, 2 Analyzer Modules (XN-20, XN-10, XN-21, or XN-11) and
1 Sampler Module (CV-55) combination ([1]), and additional 1
Analyzer Module (XN-20, XN-10, XN-21, or XN-11) and 1
Sampler Module (CV-50) combination ([2]) on 1 XN IPU (That
is to say, [1] and [2] can be connected to 1 XN IPU).
1 Analyzer Module (1 module configuration)
Analyzer
Module
+
Sampler
Module
SA-01
XN-1000 (Simplified Model)
Configurable combinations with each model are shown in Table 2. Only the combinations which include
XN-11/XN-21 are configurable, and the combinations which include XN-10/XN-20 are not configurable.
As for XN-9000/XN-9100 model, the configuration shown in above Table 1 is for one IPU. In
transportation system as a whole, multiple configurations shown in “Transportation System” of below
Table 2 may be combined.
XN-1000/1500/2000 S/M 1-23 October 2018

Table 2: Analyzer Combination List (All patterns)
Model Combination Remarks
XN-2000 ・CBC+DIFF+WPC+RET+PLT-F
XN-2800
$ $
XN-3000/XN-3100
6$6$6$
・CBC+DIFF+WPC+RET
$ $
6$6$6$
・CBC+DIFF+RET+PLT-F
% %
6$6$6$
・CBC+DIFF+PLT-F
% %
6$6$6$
・CBC+DIFF+RET
% %
6$6$6$
・CBC+DIFF
% %
6$6$6$
・CBC+DIFF+WPC+RET+PLT-F
・Place A1 on the left side facing the
$ %
front of the analyzer.
6$6$6$
・CBC+DIFF+WPC+RET
$ %
6$6$6$
% %
・Place B1 on the left side facing the
6$6$6$
XN-1000/1500/2000 S/M 1-24 October 2018

XN-2000 ・CBC+DIFF+PLT-F
XN-2800 ・Place B2 on the left side facing the
% %
XN-3000/XN-3100 front of the analyzer.
6$6$6$
・CBC+DIFF+RET
% %
6$6$6$
XN-1000 ・CBC+DIFF+WPC+RET+PLT-F
$
6$
6$
・CBC+DIFF+WPC+RET
$
6$
6$
%
6$
6$
・CBC+DIFF+PLT-F
%
6$
6$
・CBC+DIFF+RET
%
6$
6$
・CBC+DIFF
%
6$
6$
XN-1000/1500/2000 S/M 1-25 October 2018

Transportation Analyzer module type [B4, B4] (For
Model 1st test only) + Analyzer module type
[A1] (For 1st test/ Retest)
$ % %
&9 &9 &9
Analyzer module type [B4, B4] (For

1st test only) + Analyzer module type
$ % %
[A2] (For 1st test and Retest)
&9 &9 &9
・For 1st test only

・For 1st test and Retest
% % %
&9 &9 &9
For 1st test and Retest
$ $ $
&9 &9 &9
$ $ $
&9 &9 &9
% % %
&9 &9 &9
% % %
&9 &9 &9
XN-1000/1500/2000 S/M 1-26 October 2018

Transportation For 1st test and Retest
Model
% % %
&9 &9 &9
$ $
&9 &9
$ $
&9 &9
$
&9
$
&9
$ $
&9
$ $
&9
% %
&9
XN-1000/1500/2000 S/M 1-27 October 2018

Transportation For 1st test and Retest
Model
% %
&9
% %
&9
% %
&9

$ %
&9

$ %
&9

% %
&9

% %
&9

% %
&9
XN-1000/1500/2000 S/M 1-28 October 2018

Transportation Analyzer module type [B4, B4] (For
Model 1st test only) + Analyzer module type
$ % %
&9 &9
Analyzer module type [B4, B4] (For

1st test only) + Analyzer module type
$ % %
&9 &9
・For 1st test only

% % %
&9 &9
$ $ $
&9 &9
$ $ $
&9 &9
% % %
&9 &9
% % %
&9 &9
% % %
&9 &9
XN-1000/1500/2000 S/M 1-29 October 2018

1.31 XN-10/XN-20/XN-11/XN-21 Special Analysis Mode
1.31.1 Special Analysis Mode

• The special analysis mode is an analysis mode for analyzing samples besides
peripheral blood (body fluid, marrow fluid, cord blood, harvest, blood products) or for
analyzing neonatal blood.
• Analysis channels and reagents used on this mode use same channels and reagents
as the normal analysis. However, analysis conditions (dilution rate, counting time) and
analyzing data method change according to each sample.
• When analyzing in the special analysis mode, a discrete of the analysis channels is
fixed.
1.31.2 Definitions
• Body Fluid: The fluid flowing in the biological body. In an expanded sense, blood, lymph fluid,
and urine are parts of the body fluid, however, body fluid means coelomic fluid in
sample tests. The body fluid includes Cerebrospinal fluid (CSF), pleural effusion
(PE), abdominal dropsy, fluid of the joint and others.
• Total Nucleated Cell Number (TNC): Nucleated cell numbers included in the body fluid
sample, White blood cells, mesothelial cells, blood
plasma cells, histiocyte, neoplastic cells and other
nucleated cells are included in the body fluid.
1.31.3 Special Analysis Mode Configurations

(1) Configurations
• Body Fluid Mode
• HPC Mode
• hsA Mode
(2) Descriptions of each mode

Configuration Description
Body Fluid Mode WBC/TNC are counted and categorized by WDF channel.
Nucleated cells other than WBC (mesothelial cell) are detected by
enlarging the fluorescence range of WDF channel. The volume of
body fluid analysis in WDF channel is about 10µL (Its volume is 10
times bigger than the XN series WB mode or 4.4 times bigger than
the XE-500 BF mode). RBC are counted by the DC method
transducer same as the WB mode. The analyzed volume of RBC in
the BF mode is about 3.3 times bigger than the XN series standard
mode.
HPC Mode Calculating HPC# and HPC% by WPC channel.
hsA Mode WBC/Neclear cells are counted or classified on WDF channel.
Counting volume is twice as big as BF mode. RBC is computed
with DC transducer (counting volume is 3.3 times bigger of XN
series normal mode) and RET channel (counting volume is 170.7
times bigger of RET channel on XN series).
XN-1000/1500/2000 S/M 1-30 October 2018

1.31.4 Body Fluid (BF) Mode
(a) Background
The counting and classification of blood cells in body fluids (cerebrospinal fluid, pleural
effusions, ascites, synovial fluid, etc.) has been conventionally performed by manual method,
and there were issues of rapidity, personal equation, reliability of analysis result and uniform
accessibility of calculated data. In recent years, although the body fluid analysis mode is
installed in XE-5000 or XT-4000i, there is an issue such that the absolute amount to be
analyzed is not sufficient. In the body fluid mode of XN series, it realizes sufficient analytical
capacity with a small aspiration volume, which contribute to reliability improvement of test
data.
(b) Sample Cells

• Cerebrospinal fluid: (CSF)
• Pleural fluid
• Ascites fluid
• Synovial fluid
(c) Analysis Purpose

• Cerebrospinal fluid: Conducting diagnosis of inflammatory affection of central nervous system
(cerebral meningitis, encephalitis, myelitis), and subarachnoid bleeding.
• Pleural fluid: Discriminating the exudate, the transudate, the acute inflammation and
the systemic disease.
• Ascites fluid: Discriminating the exudate, the transudate, the acute inflammation and
the systemic disease.
• Synovial fluid: Discriminating the inflammatory diseases (rheumatoid arthritis, gout,
septic arthritis), and the non-inflammatory diseases (osteoarthritis,
traumatic arthritis).
(d) Analysis Channels

 - -  - - -
: Analysis channel
(e) Scattergram
Scattergram: WDF Channel (including a fluorescent range sized area)
Histogram: RBC
(f) Analysis Parameters, Display Range

(g) Reproducibility
Body fluid samples are not used for reproducibility test because body fluid deteriorate by
time advance and/or mixing. Checking the reproducibility by simulated samples created with
diluted human blood or diluted control blood.
i) WBC-BF and TC-BF#

1) 0.05- 0.15 × 102/µL: 30.0% or below
2) 0.16- 0.30 × 102/µL: 15.0% or below
3) 0.31- 0.50 × 102/µL: 10.0% or below
XN-1000/1500/2000 S/M 1-31 October 2018

ii) RBC-BF
0.3- 5.0 × 104/µL: 40.0% or below, or Max - Min ≤ 0.7 × 104/µL
(h) Accuracy
• WBC-BF, TC-BF#, RBC-BF
In correlation tests using 50 or more body fluid samples, correlation coefficients (r) and slope
of regression lines should be as follows comparing to the control method (visual method)
WBC-BF r ≥ 0.9 and slope of regression line: within 1 ± 0.3
TC-BF# r ≥ 0.9 and slope of regression line: within 1 ± 0.3
RBC-BF r ≥ 0.8 and slope of regression line: within 1 ± 0.3
• MN%, PMN%, MN#, PMN#

In correlation test using more than 50 body fluid samples, coefficient of correlation and slope
of regression line are as follows comparing to the control method (categorized with visual
method the slide created by cytospin method).
MN% r ≥ 0.7 and slope of regression line: within 1 ± 0.5
PMN% r ≥ 0.7 and slope of regression line: within 1 ± 0.5
MN# r ≥ 0.9 and slope of regression line: within 1 ± 0.5
PMN# r ≥ 0.9 and slope of regression line: within 1 ± 0.5
(i) Linearity
In specific concentration (analysis range), residual rate or residual errors or standard values
should be within a specific range. The linearity specification is based on the evaluation using
control blood.
i) Analysis Range
• WBC-BF 0.00- 100.00 × 102/µL when RBC are less than 100 × 104/µL
• TC-BF# 0.00- 100.00 × 102/µL when RBC are less than 100 × 104/µL
• RBC-BF 0.0- 500.0 × 104/µL
ii) Residual Error, Residual Rate

The residual error and the residual rate should be as follows comparing to the diluent
theoretical value.
• WBC-BF: within(0- 0.50 × 102/µL) ± 0.1 × 102/µL
within (0.50- 100.00 × 102/µL) ± 20.0%
• TC-BF#: within (0- 0.50 × 102/µL) ± 0.1 × 102/µL
within (0.50- 100.00 × 102/µL) ± 20.0%
• RBC-BF: ± 2.0% or ± 1.0 × 104/µL
(j) Carryover
The carryover rate using artificial samples (Adjusting WBC-BF and TC-BF to 100.00 × 102/
µL, adjusting RBC-BF to 500.0 × 104/µL) evaluated by the test Standard TE294006 Standard
Analysis Method (Hematology instrument product) carry-over test shall be as follows.
• WBC-BF: 0.3% or 0.01 × 102/µL or lower
• TC-BF#: 0.3% or 0.01 × 102/µL or lower
• RBC-BF: 0.3% or 0.3 × 104/µL or lower
* The background check is required if analysis results are as follows:
1. WBC-BF and TC-BF#: 0.3% or 10.00 × 102/uL or lower
2. RBC-BF: 100.0 × 104/uL or higher, and when next analysis sample is low sample (such
as CSF)
XN-1000/1500/2000 S/M 1-32 October 2018

(k) Stability after collecting samples
Stability over time after collection is not specified since samples themselves change over
time after collection.
(l) Stability
i) Temperature stability
When artificial sample (such as control blood) is used, the fluctuation obtained by the test
standard TE 294011 standard analysis method shall be as follows.
• WBC-BF within 5.0%
• TC-BF# within 5.0%
• RBC-BF 3.0% or within 1.0 × 104/μL
ii) Overtime stability (Diurnal variation) (Instrument stability)

The fluctuation obtained by the test standard TE294012 standard analysis method
(Hematology instrument product) shall be as follows.
• RBC-BF within 3.0%
iii) Overtime stability (Day-to-day variation) (Instrument stability)

The fluctuation obtained by the test standard TE294013 standard analysis method
(Hematology instrument product) shall be as follows.
• RBC-BF within 5.0%
iv) Voltage stability

Not specified (It can be considered that as long as voltage stability can be guaranteed in the
standard mode, voltage stability in this mode can be guaranteed).
(m) Auto rinse (Background Check)

Repeating analysis until the value becomes within the following acceptable background
value (up to 3 times).
If the value does not become under the acceptable background value in 3 times analysis, the
background error occurs.
• WBC-BF 0.01 × 102/µL or lower
• RBC-BF 0.3 × 104/µL or lower
(n) Thoughput
40 samples/hr
(o) Required Sample Volume

Amount of sample aspiration 88μL
Necessary amount of samples 1mL
(p) Required Reagent Volume

CELLPACK DCL 41.4mL
LYSERCELL WDF 1.5mL
FLUOROCELL WDF 0.02mL
XN-1000/1500/2000 S/M 1-33 October 2018

1.31.5 HPC Mode
(a) Background
Previously, stem cell source (bone marrow liquid, peripheral blood stem cell, cord blood) in
stem cell transfusion was analyzed or classified in FCM method. There were reliability issues
of analysis results caused by cost, rapidity and personal equation (technician, facility). In
recent years, although HPC parameters can be analyzed in SE-9000 and XE-5000, there are
issues in terms of performance such as deviation from FCM method. In the HPC mode of the
XN series, by improving the performance of stem cell quantification by contributing functions
such as optimization of analysis conditions and increase of analytical capacity, it contributes
to clinical (cell therapy field).
Following applications are expected.

• Providing information on the timing of collecting stem cells in peripheral blood stem cell
transplantation.
• Providing information on stem cell quantity of intermediate products during apheresis in
peripheral blood stem cell transplantation.
• Providing information on stem cell quantity information of harvest (harvested product).
• Test for umbilical cord blood transplant material.
(b) Sample
• Peripheral blood (Anticoagulant: EDTA-2K)
• Peripheral blood stem cell harvested products (North America market only)
(c) Parameters
NO. Item Parameter Channel

1 Peripheral blood cells number HPC# WPC
2 Peripheral blood cells number ratio HPC% WPC
Parameters obtained from the channels other than WPC are same as whole blood mode.
Handling for reportable/research

China: Research
North America: Reportable (FDA approved)
Europe and AP: Reportable (HPC#), Research (HPC%)
(d) Method
Manual analysis (not available in sampler mode)
Micro analysis
Micro analysis (micro tube)
(e) Analysis channel and exclusive channel

On HPC mode, an exclusive channel is used. HPC#, HPC% is analyzed on WPC channel.
Parameters other than HPC# and HPC% are also provided.
1) Exclusive analysis sequence

On exclusive analysis sequence, sample is aspirated twice per one analysis.
First sample aspiration is used for whole blood analysis and second aspiration is used
exclusively for WPC channel (HPC mode exclusive sequence), which calculate same
analysis parameters as HPC# and WB mode.
XN-1000/1500/2000 S/M 1-34 October 2018

Table 1: Channel
RBC/
Channel WPC HGB WNR WDF RET PLT-F*
PLT
First sample      
aspiration (for Same analysis process as whole blood mode.
parameters Not Analyzed
other than
HPC#, HPC%)
Second sample 
aspiration (for WPC channel
Not Analyzed
HPC#, HPC%) sequence exclusive
for HPC mode
: Analysis channel
*: Depends on instrument configuration
Table 2: Outline of WPC channel sequence for HPC mode (differences with whole blood mode)
HPC mode Whole Blood Mode Remarks

WPC Channel Approx. 13 Approx. 18 sec Proper time for HPC analysis
reaction time sec
WPC Channel 4 times 1 time For improving reproducibility.
analysis cycles 4 times analysis for WPC channel.
A scattergram is produced from the
result of 4 times analysis.
2) Quality Control
HPC# and HPC% are added to QC parameters of WB mode.
For North America market, HPC# and HPC% are subjected to HPC mode accuracy control.
3) WPC Scattergram
WPC scattergram is shown below. This is displayed in HPC screen.
Side Scattered (SSC) X Front Scattered (FSC)
HPC particles
XN-1000/1500/2000 S/M 1-35 October 2018

(f) Performance
1) Reproducibility
The coefficient of variation by analyzing 5 times with peripheral blood (HPC existing
sample) or peripheral blood stem cell harvested product (HPC existing sample) should be
in the ranged as follows. Or, mean value should be in the range as follows.
HPC# 30% or lower, or within ±15/μL
HPC% 30% or lower, or within ±1.50HPC% (North America market only)
2) Accuracy
Average value of peripheral blood with more than 20 samples or peripheral blood stem
cell harvested product with more than 20 samples compared with control method (CD34
positive cell analysis) using flow cytometry method should be in the range as follows.
HPC#: Within ±30%, or within ±10/μL
HPC% Within ±30%, or within ±0.50HPC% (North America market only)
3) Carryover
Carryover ratio after analyzing WBC high value sample (more than WBC 300.0 × 102/uL)
should be in the range as follows.
WBC-P: 0.5% or lower
(g) Throughput
1) Processing Capability
3 min 41 seconds/ sample (16 samples/ hr) [A1]
3 min 10 seconds/ sample (18 samples/ hr) [A2]
2) Sample aspiration volume

190uL
3) Required sample volume

Sampler Mode: -
Manual Mode: 1mL
Micro analysis: 0.4mL
Micro analysis (micro tube): 260uL
4) Required Reagent Volume

CELLPACK DCL: 93.5mL [A1]
82.9mL [A2]
CELLPACK DST: -
CELLPACK DFL: 3.0mL [A1]
1.5mL [A2]
SULFOLYSER: 0.5mL
LYSERCELL WNR: 2.5mL
LYSERCELL WDF: 1.5mL
LYSERCELL WPC: 4.5mL
FLUOROCELL WNR:20uL
FLUOROCELL WDF: 20uL
FLUOROCELL RET: 20uL
FLUOROCELL PLT: 20uL [only A1]
FLUOROCELL WPC: 80uL
XN-1000/1500/2000 S/M 1-36 October 2018

1.31.6 hsA Mode
(a) Background
Placed as research parameter for WBC and RBC low value sample to improve reliability by
increasing analysis volume.
(b) Supposed Sample

• Cerebrospinal fluid (Cerebrospinal fluid: CSF)
• Blood derivatives
　　Platelet derivatives (Residual RBC, Residual WBC)
　　Concentrated RBC derivatives (residual white blood cell)
Plasma derivatives (Residual RBC, Residual WBC)
(c) Purpose
Research analysis of low concentration blood cells (improvement of cerebrospinal fluid
classification accuracy, application to blood derivatives QC management).
(d) Analysis Channel

 - -  -  -
: Analyzed channels
(e) Displayed Scattergram

Scattergram: WDF channel (including fluorescence range)
Scattergram: RET channel
Histogram: RBC
(f) Analysis parameter and display range

Following parameters are research parameters.
Parameters Display range Remarks

WBC 0.000- 9999.999 × 102/μL Displayed to one decimal place for WBC-BF
RBC 0.0000- 9999.9900 × 104/μL Displayed to three decimal places for RBC-BF
RBC-O　RBC-O is used when lower than 20.0000 × 104/μL
RBC-O　RBC-I is used when higher than 20.0001 × 104/μL
RBC-I 0.00- 9999.99 × 104/μL Displayed to one decimal place for RBC-BF
RBC-O 0.0000- 99.9999 × 104/μL Displayed to three decimal places for RBC-BF
TC# 0.000- 9999.999 × 102/μL Displayed to one decimal place for TC-BF#
MN# 0.000- 9999.999 × 102/μL Displayed to one decimal place for BF mode
2
PMN# 0.000- 9999.999 × 10 /μL Displayed to one decimal place for BF mode
MN% 0.0- 100.0%
PMN% 0.0- 100.0%
HF# 0.000- 9999.999 × 102/μL Displayed to one decimal place for HF-BF#
HF% 0.0- 999.9/100WBC Displayed to one decimal place for HF-BF%
LYMPH# 0.000- 9999.999 × 102/μL
LYMPH% 0.0- 100.0%
MONO# 0.000- 9999.999 × 102/μL
MONO% 0.0- 100.0%
NEUT# 0.000- 9999.999 × 102/μL
NEUT% 0.0- 100.0%
EO# 0.000- 9999.999 × 102/μL
EO% 0.0- 100.0%
XN-1000/1500/2000 S/M 1-37 October 2018

(g) Reproducibility
Verify that the reproducibility using artificial blood of human-blood or control blood diluted.
i) WBC and TC#
1) When 0.050- 0.150 × 102/uL, 20.0% or lower
2) When 0.151- 0.301 × 102/uL, 10.0% or lower
3) When 0.301- 0.500 × 102/uL, 7.0% or lower
ii) RBC-I
When 0.3- 5.0 × 104/uL, 40.0% or lower, or Max - Min<=0.7 × 104/uL
iii) RBC-O
When 0.3000- 40.0000 × 104/uL, 3.0% or lower
(h) Accuracy
Not specified as this is research parameter.
(i) Linearity
In the specified concentration (analysis range), it must be within the range specified by the
residual ratio or residual or individual standard value for some regression line. Linearity
specification is based on evaluation using control blood.
i) Analysis range
　　WBC: 0.000- 100.000 × 102/µL (when RBC is below 100.0 × 104/µL)
　　TC#: 0.000- 100.000 × 102/µL (when RBC is below 100.0 × 104/µL)
　　RBC-I: 0.00- 500.00 × 104/µL
　　RBC-O: 0.0000- 50.0000 × 104/µL
ii) Residual ratio

Residual ratio to reference (residual value) should be as follows.
　　WBC: (0.000- 0.500 × 102/µL) Within ±0.1 × 102/µL
(0.501- 100.000 × 102/µL) Within ±20%
　　TC#: (0.000- 0.500 × 102/µL) Within ±0.1 × 102/µL
(0.501- 100.000 × 102/µL) Within ±20%
　　RBC-I: (0.00- 50.00 × 104/µL) Within ±1.0 × 104/µL
　　RBC-I: (50.01- 500.00 × 104/µL ) ±2%
　　RBC-O: (0.0000- 40.0000 × 104/µL) Within ±1.0 × 104/µL
(j) Carryover
The carryover rate using artificial samples (WBC and TC# more than 150.000×102/μL,
RBC-I more than 500.0 × 104/µL, RBC-O around 50.00×104/μL ) evaluated by the test
Standard TE294006 Standard Analysis Method (Hematology instrument product) carry-over
test shall be as follows.
　　WBC: 0.01% or lower
　　TC#: 0.01% or lower
　　RBC-I: 0.3%, or 0.30 × 104/µL or lower
　　RBC-O: 0.01% or lower
(k) Stability over time after collection

Not specified (however, if necessary, the time from collection to analysis is noted in the
Instruction for Use).
XN-1000/1500/2000 S/M 1-38 October 2018

(l) Stability
• Temperature stability
• Overtime stability (Diurnal variation) (Instrument stability)

• Overtime stability (Day-to-day variation) (Instrument stability)

• Voltage stability
(m) Auto rinse (Background Check)

Repeating analysis until the value becomes within the following acceptable background
value (up to 3 times).
If the value does not become under the acceptable background value in 3 times analysis, the
background error occurs.
　WBC: 0.010 × 102/µL or lower
　RBC-I: 0.30 × 104/µL or lower
　RBC-O: 0.0100 × 104/µL or lower
(n) Processing Capability

3 min 238 seconds (17 samples/hr)
(o) Required sample volume

Sample aspiration volume: 200µL
Required sample volume
Manual Mode Analysis: 1mL
Micro analysis: 0.4mL
Micro analysis (micro tube): 260uL
(p) Required Reagent Volume

CELLPACK DCL: 71.6mL
CELLPACK DFL: 1.5mL
FLUOROCELL RET: 20uL
LYSERCELL WDF: 2.5mL
FLUOROCELL WDF: 40uL
LYSERCELL WNR: 2.0mL
XN-1000/1500/2000 S/M 1-39 October 2018

Appendix 1
Note:
Specifications on WBC and PLT which are reportable parameters.
・WBC: WBC-N or WBC-D is applied, but since both WBC-N and WBC-D have the
same specifications, they are also described in the “WBC” column as
specifications.
・PLT: PLT-I, PLT-F or PLT-O is applied, but since the specifications of PLT-I, PLT-F
and PLT-O are different, specifications are described on each parameter’s
column and not on “PLT” column.
Appendix 1-1: Analysis parameters and specifications for XN-10/ XN-20

1. Analysis channel, Usage, Analysis mode, Precision, Analysis range, Display range,
Reportable Range (XN-10/ XN-20)
2. QC/ Calibrator/ Traceability, Reproducibility, Accuracy (XN-10/ XN-20)
3. Linearity (XN-10/ XN-20)
4. Carryover, Stability, Difference between Modules, Blank (XN-10/ XN-20)
Appendix 1-2: Analysis parameters and specifications for XN-11/ XN-21

1. Analysis channel, Usage, Analysis mode, Precision, Analysis range, Display range,
Reportable Range (XN-11/ XN-21)
XN-1000/1500/2000 S/M 1-40 October 2018

1. Analysis channel, Usage, Analysis mode, Precision,
Analysis range, Display range, Reportable Range (XN-10/ XN-20)
Note:
Reportable(*1): Becomes research parameter depending on the destination.
Reportable(*2): Becomes research parameter if there is no license.
Reportable(*3): Will not be displayed if there is no license.
Research(*1): Performance guaranteed since it may become reportable
parameter as WBC or PLT.
Research(*2): Will not be displayed if there is no license.
Reportable
Analysis WB PD BF HPC Range
Parameter name Usage Precision Analysis range Display range
channel Mode Mode Mode Mode (North America
only)
White blood WBC WNR or Report Yes Yes - Yes × 10/μL (WB Mode)　 0.0- 9999.9 × 0.3- 4400.0 ×
cell count WDF able 0.04400.0 × 102/μL 102/μL 102/μL
(PD Mode) 0.0-
1000.0 × 102/μL
Red blood cell RBC RBC/ Report Yes Yes - Yes × 104/μL 0-860 × 104/μL 0- 9999 × 104/ 1- 860 × 104/μL
count PLT able μL
Hemoglobin HGB HGB Report Yes Yes - Yes ・× 10(-1)g/dL 0.0- 26.0g/dL 0.0- 30.0g/dL 0.1- 26.0g/dL
content able ・× 10(-1)mmol/L 0.0- 16.14mmol/L 0.00-
18.62mmol/L
Hematocrit HCT RBC/ Report Yes Yes - Yes × 10(-1)% 0.0- 75.0% 0.0-100.0% 0.1- 75.0%
value PLT able
Mean red MCV RBC/ Report Yes Yes - Yes × 10(-1)fL - - -
blood cell PLT able
volume
Mean red MCH RBC/ Report Yes Yes - Yes ・× 10(-1)pg - - -
blood cell PLT, able ・amol
hemoglobin HGB
content
Mean red MCHC RBC/ Report Yes Yes - Yes ・× 10(-1)g/dL - - -
blood cell PLT, able ・× 10(-1)mmol/L
hemoglobin HGB
concentration
Platelet count PLT RBC/ Report Yes Yes - Yes × 103/μL - - -
PLT or able
RET or
PLT-F
Red blood cell RDW- RBC/ Report Yes Yes - Yes × 10(-1)fL - - -
distribution SD PLT able
width
Red blood cell RDW- RBC/ Report Yes Yes - Yes × 10(-1)% - - -
distribution CV PLT able
width
Micro Micro RBC/ Report Yes Yes - Yes × 10(-1)% - - -
erythrocyte R PLT able
ratio (*1)
Macro Macro RBC/ Report Yes Yes - Yes × 10(-1)% - - -
erythrocyte R PLT able
ratio (*1)
Platelet PDW RBC/ Report Yes Yes - Yes × 10(-1)fL - - -
distribution PLT able
width (*1)
Mean platelet MPV RBC/ Report Yes Yes - Yes × 10(-1)fL - - -
volume PLT able
Project life P-LCR RBC/ Report Yes Yes - Yes × 10(-1)% - - -
coverage ratio PLT able
(*1)
XN-1000/1500/2000 S/M 1-41 October 2018

Reportable
only)
Platelet crit PCT RBC/ Report Yes Yes - Yes × 10(-2)% - - -
value PLT able
(*1)
Platelet count PLT-I RBC/ Resea Yes Yes - Yes × 103/μL (WB Mode) 0.0- 0.0- 999.9 × 0.2- 500.0 × 104/
(PLT Channel) PLT rch(*1) 500.0 × 104/μL 104/μL μL
(PD Mode) 0.0-
100.0 × 104/μL
Nucleated red NRBC WNR Report Yes Yes - Yes × 10/μL (WB Mode) 0.0- 0.0- 9999.9 × 0.1- 200.0 × 102/
blood cell # able 200.0 × 102/μL 102/μL μL
count
Nucleated red NRBC WNR Report Yes Yes - Yes × 10(-1)/100WBC (WB Mode) 0.0- 0.0- 9999.9/ 0.0- 600.0/
blood cell ratio % able 600.0/100WBC 100WBC 100WBC
Neutrophil NEUT WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
count # WNR able 102/μL
Lymphocyte LYMP WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
count H# WNR able 102/μL
Monocytes MON WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
count O# WNR able 102/μL
Eosinophil EO# WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
count WNR able 102/μL
Basophils BASO WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
Neutrophil NEUT WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
ratio % WNR able
Lymphocyte LYMP WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
ratio H% WNR able
Monocyte ratio MON WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
O% WNR able
Eosinophil EO% WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
ratio WNR able
Basophil ratio BASO WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
% WNR able
Immature IG# WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
granulocyte WNR able 102/μL
count (*1)
Immature IG% WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
granulocyte WNR able
ratio (*1)
AS-LYMP# AS- WDF, Report Yes Yes - Yes × 10/μL - 0.0- 9999.9 × -
LYMP WNR able 102/μL
# (*3)
AS-LYMP% AS- WDF, Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% -
LYMP WNR able
% (*3)
RE-LYMP# RE- WDF, Report Yes Yes - Yes × 10/μL - 0.0- 9999.9 × 0.3- 4400.0 ×
LYMP WNR able 102/μL 102/μL
# (*3)
RE-LYMP% RE- WDF, Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% 0.0- 100.0%
LYMP WNR able
% (*3)
Neutrophil NEUT- WDF Report Yes Yes - Yes × 10(-1)FI - 0.0- 999.9 (FI) -
reactive RI able
intensity (*3)
Neutrophil NEUT- WDF Report Yes Yes - Yes × 10(-1)SI - 0.0- 999.9 (SI) -
granular GI able
intensity (*3)
Hematopoietic HPC# WPC(HP Report - - - Yes /μL - 0.00- 999.99 × -
precursor cell C mode) able 102/μL
number (*1)
Hematopoietic HPC% WPC(HP Report - - - Yes × 10(-2)% - 0.00- 99.99% -
precursor cell C mode) able
number ratio (*1)
XN-1000/1500/2000 S/M 1-42 October 2018

Reportable
only)
Reticulocyte RET% RET Report Yes Yes - Yes × 10(-2)% (WB Mode)0.00- 0.00- 99.99% 0.00- 30.00%
ratio able 30.00%
Reticulocyte RET# RET, Report Yes Yes - Yes × 10(-2)/μL (WB Mode)0.00- 0.00- 99.99 × 1.00- 72.00 ×
count RBC/ able 72.00 × 104/μL 104/μL 104/μL
PLT
Immature IRF RET Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% 0.0-100.0%
reticulocyte able
fraction
Low LFR RET Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% -
fluorescence able
reticulocyte (*1)
ratio
Medium MFR RET Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% -
fluorescence able
reticulocyte (*1)
ratio
High HFR RET Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% -
fluorescence able
reticulocyte (*1)
ratio
Platelet count PLT-O RET Resea Yes Yes - Yes × 103/μL (WB Mode) 0.0- 0.0- 999.9×104/ -
(RET channel) rch(*1) 500.0 × 104/μL μL
(PD Mode) 0.0-
100.0 × 104/μL
Reticulocyte RET- RET Report Yes Yes - Yes ・× 10(-1)pg - -
hemoglobin He able ・amol
equivalent (*1)
Red blood cell RBC- RET Report Yes Yes - Yes ・× 10(-1)pg - 0.0- 999.9 (pg) -
equivalent (*1)
Delta-He Delta- RET Report Yes Yes - Yes ・× 10(-1)pg - -999.9- -999.9 -
He able ・amol (pg)
(*1)
HYPO-He HYPO RET Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% -
-He able
(*1)
HYPER-He HYPE RET Report Yes Yes - Yes × 10(-1)% - 0.0-100.0% -
R-He able
(*1)
Platelet count PLT-F PLT-F Resea Yes Yes - Yes × 103/μL (WB Mode) 0.0- 0.0- 999.9 × 0.2- 500.0 × 104/
(PLT-F rch(*1) 500.0 × 104/μL 104/μL μL
channel) (PD Mode) 0.0-
100.0 × 104/μL
Immature IPF PLT-F Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% 0.0- 100.0%
platelets ratio able
(*1)
Immature IPF# PLT-F Report Yes Yes - Yes × 102/μL - 0.0- 999.9 × 0.2- 500.0 × 103/
platelet count able 103/μL μL
(*1)
White blood WBC- WDF(BF Report - - Yes - /μL 0.00- 100.00 × 102/ 0.00- 9999.99 × 0.03- 100.00 ×
cell count BF mode, able µL 102/μL 102/µL
(Body fluid) CSF
mode)
Red blood cell RBC- RBC(BF Report - - Yes - × 103/μL 0.0- 500.0 × 104/µL 0.0- 0.2- 500.0 × 104/
4
count BF mode) or able 9999.9×10 /μL µL
(Body fluid) RET(CS
F mode)
Mononuclear MN# WDF(BF Report - - Yes - /μL - 0.00- 9999.99 × 0.03- 100.00 ×
cell count mode, able 102/μL 102/µL
(Body fluid) CSF
mode)
XN-1000/1500/2000 S/M 1-43 October 2018

Reportable
only)
Polymorphonu PMN# WDF(BF Report - - Yes - /μL - 0.00- 9999.99 × 0.03- 100.00 ×
clear cell mode, able 102/μL 102/µL
count CSF
(Body fluid) mode)
Mononuclear MN% WDF(BF Report - - Yes - × 10(-1)% - 0.0- 100.0% / 0.0- 100.0%
cell ratio mode, able 0.000-
(Body fluid) CSF 1.000Ratio
mode)
Polymorphonu PMN WDF(BF Report - - Yes - × 10(-1)% - 0.0- 100.0% / 0.0- 100.0%
clear cell ratio % mode, able 0.000- 1.000
(Body fluid) CSF Ratio
mode)
Total TC- WDF(BF Report - - Yes - /μL 0.00-100.00×102/µL 0.03- 100.00 ×
nucleated cell BF# mode, able 102/µL
count CSF (*1)
(Body fluid) mode)
Total TNC WNR or Resea Yes Yes - Yes × 10/μL - 0.0- 9999.9 × -
nucleated cell WDF rch 102/μL
count
White blood WBC- WNR Resea Yes Yes - Yes × 10/μL (WB Mode) 0.0- 0.0- 9999.9 × -
cell count N rch(*1) 4400.0 × 102/μL 102/μL
(WNR (PD Mode) 0.0-
channel) 1000.0 × 102/μL
Total TNC- WNR Resea Yes Yes - Yes × 10/μL - 0.0-9999.9 × -
nucleated cell N rch 102/μL
number
(WNR
channel)
White blood WBC- WDF Resea Yes Yes - Yes × 10/μL (WB Mode) 0.0- 0.0- 9999.9 × -
cell count D rch(*1) 4400.0 × 102/μL 102/μL
(WDF (PD Mode) 0.0-
channel) 1000.0 × 102/μL
Total TNC- WDF Resea Yes Yes - Yes × 10/μL - 0.0-9999.9 × -
nucleated cell D rch 102/μL
count
(WDF
channel)
White blood WBC- WPC Resea Yes - - Yes × 10/μL - 0.0-9999.9 × -
cell count P rch 102/μL
(WPC
channel)
Total TNC- WPC Resea Yes - - Yes × 10/μL - 0.0- 9999.9 × -
nucleated cell P rch 102/μL
count
(WPC
channel)
Red blood cell RBC- RET Resea Yes Yes - Yes × 104/μL - 0- 9999 × 104/ -
count (RET O rch μL
channel)
- NEUT WDF, Resea Yes Yes - Yes × 10/μL - - -
#& WNR rch
- NEUT WDF, Resea Yes Yes - Yes × 10(-1)% - - -
%& WNR rch
- LYMP WDF, Resea Yes Yes - Yes × 10/μL - - -
#& WNR rch
- LYMP WDF, Resea Yes Yes - Yes × 10(-1)% - - -
%& WNR rch
- HFLC WDF, Resea Yes Yes - Yes × 10/μL - - -
# WNR rch
- HFLC WDF, Resea Yes Yes - Yes × 10(-1)% - - -
% WNR rch
XN-1000/1500/2000 S/M 1-44 October 2018

Reportable
only)
- AS- WDF, Resea Yes Yes - Yes × 10(-1)% - - -
LYMP WNR rch
%L
- RE- WDF, Resea Yes Yes - Yes × 10(-1)% - - -
LYMP WNR rch
%L
Basophils BA-N# WNR Resea Yes Yes - Yes × 10/μL - - -
count rch
(WNR
channel)
Basophil ratio BA- WNR Resea Yes Yes - Yes × 10(-1)% - - -
(WNR N% rch
channel)
Basophils BA-D# WDF, Resea Yes Yes - Yes × 10/μL - - -
count WNR rch
(WDF
channel)
Basophil ratio BA- WDF, Resea Yes Yes - Yes × 10(-1)% - - -
(WDF D% WNR rch
channel)
- NE- WDF Resea Yes Yes - Yes × 10(-1)ch - - -
SSC rch
SFL rch
FSC rch
- LY-X WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- LY-Y WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- LY-Z WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- MO-X WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- MO-Y WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- MO-Z WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- NE- WDF Resea Yes Yes - Yes None - - -
WX rch
WY rch
WZ rch
- LY-WX WDF Resea Yes Yes - Yes None - - -
rch
- LY-WY WDF Resea Yes Yes - Yes None - - -
rch
- LY-WZ WDF Resea Yes Yes - Yes None - - -
rch
- MO- WDF Resea Yes Yes - Yes None - - -
WX rch
WY rch
WZ rch
- RET-Y RET Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- RET- RET Resea Yes Yes - Yes × 10(-1)ch - - -
RBC- rch
Y
XN-1000/1500/2000 S/M 1-45 October 2018

Reportable
only)
- IRF-Y RET Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- FRC# RET, Resea Yes Yes - Yes × 102/μL - - -
RBC/ rch
PLT
- FRC% RET Resea Yes Yes - Yes × 10(-2)% - - -
rch
Reticulocyte RPI RET, Resea Yes Yes - Yes None - - -
production RBC/ rch
index PLT
- RET- RET Resea Yes Yes - Yes × 102/μL - - -
UPP rch
TNC rch
- H-IPF PLT-F Resea Yes Yes - Yes × 10(-1)% - - -
rch
- HF- WDF(BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- HF- WDF(BF Resea - - Yes - × 10(-1)/100WBC - - -
BF% mode, rch
CSF
mode)
- NE- WDF(BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- NE- WDF(BF Resea - - Yes - × 10(-1)% - - -
BF% mode, rch
CSF
mode)
- LY- WDF(BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- LY- WDF(BF Resea - - Yes - × 10(-1)% - - -
BF% mode, rch
CSF
mode)
- MO- WDF(BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- MO- WDF(BF Resea - - Yes - × 10(-1)% - - -
BF% mode, rch
CSF
mode)
- EO- WDF(BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- EO- WDF(BF Resea - - Yes - × 10(-1)% - - -
BF% mode, rch
CSF
mode)
- RBC- RBC(BF Resea - - Yes - × 102/μL - - -
BF2 mode) or rch
RET(CS
F mode)
XN-1000/1500/2000 S/M 1-46 October 2018

QC/ Calibrator/ Traceability Reproducibility Accuracy
QC Traceabi WB Mode, BF WB Mode, BF

Parameter name Calibrator PD Mode Condition PD Mode
material lity HPC Mode Mode HPC Mode Mode
White blood WBC XN XN CAL ICSH ・3.0% or 5.0% or - 40.0 × 102/μL or within ±3% or within -
cell count CHECK reference lower lower higher ±2.0 × 102/μL ±10%
method ・(Low
value
reference
at 15.0 ×
102/μL)
8.0% or
lower
・(Low
value
reference
at 5.0 ×
102/μL)
15.0% or
lower
Red blood cell RBC XN XN CAL ICSH 1.5% or 4.5% or - 400 × 104/μL or within ±2% or ±3 × within -
count CHECK reference lower lower higher 104/μL ±8%
method
Hemoglobin HGB XN XN CAL ICSH 1.0% or 3.0% or - - within ±2% or within -
content CHECK reference lower lower ±0.2g/dL ±5%
method
Hematocrit HCT XN XN CAL ICSH 1.5% or 4.5% or - - within ±3% or within -
value CHECK reference lower lower ±1.0 HCT ±4% or
method ±2.0 HCT
Mean red MCV XN - (calculati 1.0% or 4.5% or - - within ±3% or within -
blood cell CHECK on: RBC, lower lower ±2.0fL ±4% or
volume HCT) ±3.0fL
Mean red MCH XN - (calculati 2.0% or 4.5% or - - - - -
blood cell CHECK on: RBC, lower lower
hemoglobin HGB)
content
Mean red MCHC XN - (calculati 2.0% or 6.0% or - - - - -
blood cell CHECK on: HCT, lower lower
hemoglobin HGB)
concentration
Platelet count PLT PLT- PLT-I: XN ICSH - - - - - - -
I:XN CAL reference
CHECK PLT-O: method
PLT- XN CAL
O:XN PLT-F: XN
CHECK CAL PF
PLT-
F:XN
CHECK
Red blood cell RDW- XN - - 2.0% or 6.0% or - - - - -
distribution SD CHECK lower lower
width
distribution CV CHECK lower lower
width
Micro Micro XN - - 15.0% or 36.0% or - - - - -
erythrocyte R CHECK lower, or lower, or
ratio within within
±1.0Micro ±2.0Micro
R R
XN-1000/1500/2000 S/M 1-47 October 2018


Macro Macro XN - - 15.0% or 36.0% or - - - - -
erythrocyte R CHECK lower,　or lower, or
ratio within within
±1.0Macro ±2.0Macro
R R
Platelet PDW XN - - 10.0% or 20.0% or - - - - -
distribution CHECK lower lower
width
Mean platelet MPV XN - - 4.0% or 8.0% or - - within ±5% or within -
volume CHECK lower lower ±1.0fL ±7% or
(PLT 10.0 × 104/μL ±1.5fL
or higher) (PLT
10.0 ×
104/μL or
higher)
Project life P-LCR XN - - 15.0% or 36.0% or - - - - -
coverage ratio CHECK lower lower
Platelet crit PCT XN - - 6.0% or 12.0% or - - within ±5% or within -
value CHECK lower lower ±0.03 PCT ±7% or
(PLT 10.0 × 104/μL ±0.04
or higher) PCT
(PLT
10.0 ×
104/μL or
higher)
Platelet count PLT-I XN XN CAL - ・4.0% or 12.0% or - 10.0 × 104/μL or within ±5% or ±1.0 within -
(PLT CHECK lower lower higher × 104/μL ±10%
Channel) ・(Low
value
reference
at 5.0 ×
104/μL)
8.0% or
lower
・(Low
value
reference
at 3 × 104/
μL) 10.0%
or lower
Nucleated red NRBC XN - SYSMEX 25.0% or 50.0% or - - - - -
blood cell # CHECK internal lower, or lower, or
count method within ±1.2 within ±2.5
(FCM) × 102/μL × 102/μL
Nucleated red NRBC XN - SYSMEX 25.0% or 50.0% or - WBC 40.0 × r ≥ 0.80 r ≥ 0.70 -
blood cell % CHECK internal lower, or lower, or 102/μL or higher
ratio method within ±1.5 within
(FCM) NRBC% ±3.0
NRBC%
Neutrophil NEUT XN - SYSMEX 8.0% or 16.0% or - 12.0 × 102/μL or - - -
count # CHECK internal lower lower higher
method
(FCM)
Lymphocyte LYMP XN - SYSMEX 8.0% or 16.0% or - 6.0 × 102/μL or - - -
count H# CHECK internal lower lower higher
method
(FCM)
Monocytes MONO XN - SYSMEX 20.0% or 40.0% or - 2.0 × 102/μL or - - -
method
(FCM)
XN-1000/1500/2000 S/M 1-48 October 2018


Eosinophil EO# XN - SYSMEX 25.0% or 40.0% or - - - - -
count CHECK internal lower, or lower
method within ±1.2
(FCM) × 102/μL
Basophils BASO XN - SYSMEX 40.0% or 50.0% or - - - - -
count # CHECK internal lower, or lower, or
method within ±0.6 within
(FCM) × 102/μL ±0.6 × 102/
μL
Neutrophil NEUT XN - SYSMEX 8.0% or 16.0% or - 30.0 NEUT% or 1) r ≥ 0.90 1) r ≥ -
ratio % CHECK internal lower lower higher, 2) within ±3.0 0.70
method WBC 40.0 × NEUT% 2) within
(FCM) 102/μL or higher ±3.0
North America NEUT%
market only
1) r ≥ 0.90
2) ±10% or within
±3.0 NEUT%
Lymphocyte LYMP XN - SYSMEX 8.0% or 16.0% or - 15.0 LYMPH% 1) r ≥ 0.90 1) r ≥ -
ratio H% CHECK internal lower lower or higher, 2) within ±3.0 0.70
method WBC 40.0 × LYMPH% 2) within
North America LYMPH
market only %
1) r ≥ 0.90
2) ±10% or within
±3.0 LYMPH%
Monocyte MONO XN - SYSMEX 20.0% or 40.0% or - 5.0 MONO% or 1) r ≥ 0.75 1) r ≥ -
ratio % CHECK internal lower lower higher, 2) within ±2.0 0.60
method WBC 40.0 × MONO% 2) within
North America MONO%
market only
1) r ≥ 0.75
2) ±10% or within
±2.0 MONO%
Eosinophil EO% XN - SYSMEX 25.0% or 40.0% or - WBC 40.0 × 1) r ≥ 0.80 1) r ≥ -
ratio CHECK internal lower, or lower 102/μL or higher 2) within ±1.0 0.60
method within ±1.5 EO% 2) within
(FCM) EO% ±1.0
North America EO%
market only
1) r ≥ 0.80
2) within ±10% or
±1.0 EO%
Basophil ratio BASO XN - SYSMEX 40.0% or 50.0% or - WBC 40.0 × 1) r ≥ 0.50 1) r ≥ -
% CHECK internal lower, or lower, or 102/μL or higher 2) within ±1.0 0.50
method within ±1.0 within ±1.5 BASO% 2) within
(FCM) BASO% BASO% ±1.0
North America BASO%
market only
1) r ≥ 0.50
2) ±10% or within
±1.0 BASO%
Immature IG# XN - SYSMEX 25.0% or 75.0% or - IG# 1.0 × 102/ - - -
granulocyte CHECK internal lower, or lower or μL or higher
(FCM) × 102/μL × 102/μL
XN-1000/1500/2000 S/M 1-49 October 2018


Immature IG% XN - SYSMEX 25.0% or 75.0% or - IG% 2.0% or 1) r ≥ 0.80 - -
granulocyte CHECK internal lower, or lower, or higher, 2) within ±1.5 IG%
ratio method within ±1.5 within WBC 40.0 ×
(FCM) IG% ±4.5 IG% 102/μL or higher North America
market only
1) r ≥ 0.80
2) within ±10% or
±1.5 IG%
AS-LYMP# AS- XN - - 20.0% or 40.0% or - 6.0 × 102/μL or - - -
LYMP CHECK lower lower higher
#
AS-LYMP% AS- XN - - 20.0% or 40.0% or - 15.0 LYMPH% - - -
LYMP CHECK lower lower or higher,
% WBC 40.0 ×
102/μL or higher
RE-LYMP# RE- XN - - 20.0% or 40.0% or - 6.0 × 102/μL or - - -
LYMP CHECK lower lower higher
#
RE-LYMP% RE- XN - - 20.0% or 40.0% or - 15.0 LYMPH% - - -
LYMP CHECK lower lower or higher,
% WBC 40.0 ×
102/μL or higher
Neutrophil NEUT- XN - - 3.0% or 6.0% or - NEUT# 12.0 × - - -
reactive RI CHECK lower lower 102/μL or higher
intensity
Neutrophil NEUT- XN - - 3.0% or 6.0% or - NEUT# 12.0 × - - -
granular GI CHECK lower lower 102/μL or higher
intensity
Hematopoietic HPC# XN - - 30.0% or - - In the case of within HPC% - -
precursor cell CHECK lower, or continuous ±30% or ±0.50
number within ±15/ analysis of HPC%
μL peripheral blood (In both cases
(HPC existing where 20 or more
sample) 5 times peripheral blood
or more and in samples were
the case of analyzed and
continuous when 20 or more
analysis of of peripheral blood
peripheral blood stem cell collection
stem cell products samples
harvested were analyzed, the
product (HPC average value
existing sample) analyzed using the
5 times or more, control method
the value shall (CD34 positive cell
be within the analysis) using the
range stated on flow cytometry
the left. method, shall be
*Peripheral within the above
blood stem cell range.)
collection *Peripheral blood
product (HPC stem cell collection
existing sample) product (HPC
is for North existing sample) is
America market for North America
only market only
XN-1000/1500/2000 S/M 1-50 October 2018


Hematopoietic HPC% XN - - HPC% - - In the case of within HPC% - -
precursor cell CHECK 30.0% or continuous ±30% or ±0.50
number ratio lower, or analysis of HPC%
within peripheral blood (In both cases
±1.50 (HPC existing where 20 or more
HPC% sample) 5 times peripheral blood
or more and in samples were
the case of analyzed and
continuous when 20 or more
analysis of of peripheral blood
peripheral blood stem cell collection
stem cell products samples
harvested were analyzed, the
product (HPC average value
existing sample) analyzed using the
5 times or more, control method
the value shall (CD34 positive cell
be within the analysis) using the
range stated on flow cytometry
the left. method, shall be
*Peripheral within the above
blood stem cell range.)
collection *Peripheral blood
product (HPC stem cell collection
existing sample) product (HPC
is for North existing sample) is
America market for North America
only market only
Reticulocyte RET% XN - Manual 15.0% or 35.0% or - RBC 300 × 104/ 1) r ≥ 0.90 1) r ≥ -
ratio CHECK method lower lower μL or higher, 2) within ±20% or 0.80
(CLSI RET% 1.00- ±0.30 RET% 2) within
H44-A2) 4.00% ±30% or
±0.50
RET%
Reticulocyte RET# XN - (calculati 15.0% or 35.0% or - RBC 300 × 104/ 1) r ≥ 0.90 1) r ≥ -
count CHECK on: lower lower μL or higher, 2) within ±20% or 0.80
RET%, RET% 1.00- ±1.50 × 104/μL 2) within
RBC) 4.00% ±30% or
±2.0 ×
104/μL
Immature IRF XN - - 30.0% or - - RBC 300 × 104/ within ±30% or within -
reticulocyte CHECK lower μL or higher, ±10.0 IRF ±50% or
fraction RET% 1.00- (In case of control ±10.0
4.00%, IRF blood or calibrator, IRF
20.0% or higher within 40.0IRF)
Low LFR XN - - 30.0% or - - RBC 300 × 104/ ±30% or within within -
fluorescence CHECK lower μL or higher, ±10.0 LFR ±50% or
reticulocyte RET% 1.00- (In case of control ±10.0
ratio 4.00%, LFR blood or calibrator, LFR
20.0% or higher within 35.0 LFR)
Medium MFR XN - - 50.0% or - - RBC 300 × 104/ within ±30% or within -
fluorescence CHECK lower μL or higher, ±10.0 MFR ±50% or
reticulocyte RET% 1.00- (In case of control ±10.0
ratio 4.00%, LFR blood or calibrator, MFR
20.0% or higher within 30.0 MFR)
High HFR XN - - 100.0% or - - RBC 300 × 104/ ±30% or within within -
fluorescence CHECK lower, or μL or higher, ±5.0 HFR ±50% or
reticulocyte within ±2.0 RET% 1.00- (In case of control ±5.0 HFR
ratio HFR 4.00% blood or calibrator,
within 15.0 HFR)
XN-1000/1500/2000 S/M 1-51 October 2018


Platelet count PLT-O XN XN CAL - 6.0% or 13.0% or - 10.0 × 104/μL or Within ±7% or Within -
(RET CHECK lower lower higher ±1.0 × 104/μL ±15%
channel)
Reticulocyte RET- XN - - 5.0% or - - RET# 2.00 × r ≥ 0.9 r ≥ 0.7 -
hemoglobin He CHECK lower 104/μL or higher (Including more
equivalent than half of
samples with RET
# 2.0 × 104 / μL or
more, out of the
number of
samples to be
analyzed)
Red blood cell RBC- XN - - 5.0% or - - - r ≥ 0.9 r ≥ 0.7 -
hemoglobin He CHECK lower
equivalent
Delta-He Delta- XN - - RET-He - - RET# 2.00 × RET-He r ≥ 0.9, RET-He r -
He CHECK 5.0% or 104/μL or higher and RBC-He r ≥ ≥ 0.7
lower and, 0.9 and,
RBC-He RBC-He
5.0% or r ≥ 0.7
lower
HYPO-He HYPO - - - 25.0% or - - - - - -
-He lower, or
within
±1.0HYPO
-He
HYPER-He HYPE - - - 25.0% or - - - - - -
R-He lower, or
within
±1.0HYPE
R-He
Platelet count PLT-F XN XN CAL ICSH 1) 2.5% or 1) 5.0% or - 1) PLT 10.0 × Within ±5% or Within -
(PLT-F CHECK PF reference lower lower 104/μL or higher ±1.0 × 104/μL ±10%
channel) method 2) 5.0% or 2) 10.0% 2) PLT 2.0 ×
lower or lower 104/μL or higher
Immature IPF XN - - 1) 25.0% 40.0% or - 1) PLT 5.0 × r ≥ 0.8 r ≥ 0.5 -
platelets ratio CHECK or lower lower 104/μL or
2) higher, IPF
(Analyzed 3.0% or higher
value of 2) PLT 1.0- 5.0
coefficient × 104/μL, IPF
of 10.0% or higher
variation)
20.0% or
lower
Immature IPF# XN - - 1) 25.0% 40.0% or - 1) PLT 5.0 × r ≥ 0.8 r ≥ 0.5 -
platelet count CHECK or lower lower 104/μL or
2) higher, IPF
of 10.0% or higher
variation)
20.0% or
lower
XN-1000/1500/2000 S/M 1-52 October 2018


White blood WBC- XN - Manual - - 1) 1) 0.05- 0.15 × - - r ≥ 0.9
cell count BF CHECK method 30.0% 102/μL and the
(Body fluid) BF (CLSI or lower 2) 0.16- 0.30 × inclinati
H56-A) 2) 102/μL on of the
15.0% 3)0.31- 0.50 × regressi
or lower 102/μL on line
3)10.0% within 1
or lower ± 0.3
Red blood cell RBC- XN - Manual - - 40.0% 0.3- 5.0 × 104/ - - and the
count BF CHECK method or lower μL inclinati
(Body fluid) BF (CLSI or on of the
H56-A) Max-Min regressi
≤ 0.7 × on line
104/μL within
1±0.3
Mononuclear MN# XN - Manual - - - - - - r ≥ 0.9
cell count CHECK method and the
(Body fluid) BF (CLSI inclinati
H56-A) on of the
regressi
on line
within
1±0.5
Polymorphon PMN# XN - Manual - - - - - - r ≥ 0.9
uclear cell CHECK method and the
count BF (CLSI inclinati
(Body fluid) H56-A) on of the
regressi
on line
within
1±0.5
Mononuclear MN% XN - Manual - - - - - - r ≥ 0.7
cell ratio CHECK method and the
H56-A) on of the
regressi
on line
within
1±0.5
Polymorphon PMN% XN - Manual - - - - - - r ≥ 0.7
ratio BF (CLSI inclinati
regressi
on line
within
1±0.5
Total TC- XN - - - - 1) 1) 0.05- 0.15 × - - r ≥ 0.9
nucleated cell BF# CHECK 30.0% 102/μL and the
count BF or lower 2) 0.16- 0.30 × inclinati
(Body fluid) 2)15.0% 102/μL on of the
or lower 3)0.31- 0.50 × regressi
3)10.0% 102/μL on line
or lower within
1±0.3
Total TNC - - - - - - - - - -
nucleated cell
count
XN-1000/1500/2000 S/M 1-53 October 2018


White blood WBC- - - - ・3.0% or 5.0% or - 40.0 × 102/μL or Within ±3% or Within -
cell count N lower lower higher ±2.0 × 102/μL ±10%
(WNR ・(Low
channel) value
reference
at 15.0 ×
102/μL)
8.0% or
lower
・(Low
value
reference
at 5.0 ×
102/μL)
15.0% or
lower
Total TNC-N - - - - - - - - - -
nucleated cell
number
(WNR
channel)
White blood WBC- XN XN CAL - ・3.0% or 5.0% or - 40.0 × 102/μL or Within ±3% or Within -
cell count D CHECK lower lower higher ±2.0 × 102/μL ±10%
(WDF ・(Low
channel) value
reference
at 15.0 ×
102/μL)
8.0% or
lower
・(Low
value
reference
at 5.0 ×
102/μL)
15.0% or
lower
Total TNC-D - - - - - - - - - -
nucleated cell
count
(WDF
channel)
White blood WBC- XN XN CAL - - - - - - - -
cell count P CHECK
(WPC
channel)
Total TNC-P - - - - - - - - - -
nucleated cell
count
(WPC
channel)
Red blood cell RBC- XN XN CAL - - - - - - - -
count (RET O CHECK
channel)
- NEUT - - - - - - - - - -
#&
- NEUT - - - - - - - - - -
%&
- LYMP - - - - - - - - - -
#&
XN-1000/1500/2000 S/M 1-54 October 2018


- LYMP - - - - - - - - - -
%&
- HFLC - - - - - - - - - -
#
- HFLC - - - - - - - - - -
%
- AS- - - - - - - - - - -
LYMP
%L
- RE- - - - - - - - - - -
LYMP
%L
Basophils BA-N# - - - - - - - - - -
count
(WNR
channel)
Basophil ratio BA- - - - - - - - - - -
(WNR N%
channel)
Basophils BA-D# - - - - - - - - - -
count
(WDF
channel)
(WDF D%
channel)
- NE- - - - - - - - - - -
SSC
- NE- - - - - - - - - - -
SFL
- NE- - - - - - - - - - -
FSC
- LY-X - - - - - - - - - -
- LY-Y - - - - - - - - - -
- LY-Z - - - - - - - - - -
- MO-X - - - - - - - - - -
- MO-Y - - - - - - - - - -
- MO-Z - - - - - - - - - -
- NE- - - - - - - - - - -
WX
- NE- - - - - - - - - - -
WY
- NE- - - - - - - - - - -
WZ
- LY-WX - - - - - - - - - -
- LY-WY - - - - - - - - - -
- LY-WZ - - - - - - - - - -
- MO- - - - - - - - - - -
WX
- MO- - - - - - - - - - -
WY
- MO- - - - - - - - - - -
WZ
- RET-Y - - - - - - - - - -
- RET- XN XN CAL - - - - - - - -
RBC-Y CHECK
XN-1000/1500/2000 S/M 1-55 October 2018


- IRF-Y - - - - - - - - - -
- FRC# - - - - - - - - - -
- FRC% - - - - - - - - - -
Reticulocyte RPI - - - - - - - - - -
production
index
- RET- - - - - - - - - - -
UPP
- RET- - - - - - - - - - -
TNC
- H-IPF - - - - - - - - - -
- HF- - - - - - - - - - -
BF#
- HF- - - - - - - - - - -
BF%
- NE- - - - - - - - - - -
BF#
- NE- - - - - - - - - - -
BF%
- LY- - - - - - - - - - -
BF#
- LY- - - - - - - - - - -
BF%
- MO- - - - - - - - - - -
BF#
- MO- - - - - - - - - - -
BF%
- EO- - - - - - - - - - -
BF#
- EO- - - - - - - - - - -
BF%
- RBC- - - - - - - - - - -
BF2
XN-1000/1500/2000 S/M 1-56 October 2018

Linearity
Condition Validation using stable substance

WB Mode,
Parameter name PD Mode (WB Mode and WB Mode, Body Fluid
HPC Mode PD Mode Condition
PD Mode) HPC Mode Mode
White blood WBC within ±3% or within ±10% 0.0- 1000.0 × 1) within ±3% or 1) 2) 3) within - 1) 0.0- 1000.0 × 102/μL
cell count ±2.0 × 102/μL or ±4.0 × 102/ 102/μL ±2.0 × 102/μL ±10% or ±4.0 2) 1000.1- 3100.0 × 102/
μL 2) within ±6% × 102/μL μL
3) within ±11% 3) 3100.1- 4400.0 × 102/
μL
Red blood cell RBC within ±2% or within ±8% or 0- 800 × 104/μL within ±4% or ±6 × within ±8% or - 0- 860 × 104/μL
count ±3 × 104/μL ±6 × 104/μL 104/μL ±6 × 104/μL
Hemoglobin HGB within ±2% or within ±5% or 0.0- 25.0g/dL within ±5% or within ±5% or - 0.0- 26.0g/dL
content ±0.2g/dL ±0.5g/dL 0.00- ±0.5g/dL ±0.5g/dL 0.0- 16.14mmol/L
15.52mmol/L
Hematocrit HCT within ±3% or within ±4% or 0.0- 75.0% - - - -
value ±1.0 HCT ±2.0 HCT
Mean red MCV Fluctuation of - 200<RBC<700 - - - -
blood cell MCV by RBC ×104/μL
volume concentration
is within ±
2.0fL
Mean red MCH - - - - - - -
blood cell
hemoglobin
content
Mean red MCHC - - - - - - -
blood cell
hemoglobin
concentration
Platelet count PLT - - - - - - -
Red blood cell RDW- Fluctuation of - 200<RBC<700 - - - -
distribution SD RDW-SD by × 104/μL
width RBC
concentration
is within
±3.0fL
Red blood cell RDW- Fluctuation of - 200<RBC<700 - - - -
distribution CV RDW-CV by × 104/μL
width RBC
concentration
is within ±1.0
RDW-CV
Micro Micro - - - - - - -
erythrocyte R
ratio
Macro Macro - - - - - - -
erythrocyte R
ratio
Platelet PDW - - - - - - -
distribution
width
Mean platelet MPV - - - - - - -
volume
Project life P-LCR - - - - - - -
coverage ratio
Platelet crit PCT - - - - - - -
value
XN-1000/1500/2000 S/M 1-57 October 2018

Linearity

WB Mode,
Platelet count PLT-I 1) within ±5% 1) within 1) 0.0- 100.0 × 1) within ±5% or 1) 2) within - 1) 0.0- 100.0 × 104/μL
(PLT or ±1.0 × 104/ ±10% or ±2.0 104/μL ±1.0 × 104/μL ±10% or ±2.0 2) 100.1- 500.0 × 104/μL
Channel) μL × 104/μL (Approx. 400 × 2) within ±6% × 104/μL
2) PLT 104/μL in case
fluctuation of RBC)
within ± 2.0 × 2)
104/μL 200<RBC<700
against the ×104/μL
influence of
RBC (Approx.
30.0 × 104/μL
in case of
PLT )
Nucleated red NRBC - - - within ±10% or within ±10% or - 0.0- 200.0 × 102/μL
blood cell # ±2.0 × 102/μL ±2.0 × 102/μL
count
Nucleated red NRBC - - - within ±20% or within ±20% or - 0.0- 600.0/100WBC
blood cell % ±2.0 NRBC% ±2.0 NRBC%
ratio
Neutrophil NEUT - - - - - - -
count #
Lymphocyte LYMP - - - - - - -
count H#
Monocytes MONO - - - - - - -
count #
Eosinophil EO# - - - - - - -
count
Basophils BASO - - - - - - -
count #
Neutrophil NEUT - - - - - - -
ratio %
Lymphocyte LYMP - - - - - - -
ratio H%
Monocyte MONO - - - - - - -
ratio %
Eosinophil EO% - - - - - - -
ratio
Basophil ratio BASO - - - - - - -
%
Immature IG# - - - - - - -
granulocyte
count
Immature IG% - - - - - - -
granulocyte
ratio
AS-LYMP# AS- - - - - - - -
LYMP
#
AS-LYMP% AS- - - - - - - -
LYMP
%
RE-LYMP# RE- - - - - - - -
LYMP
#
RE-LYMP% RE- - - - - - - -
LYMP
%
Neutrophil NEUT- - - - - - - -
reactive RI
intensity
XN-1000/1500/2000 S/M 1-58 October 2018

Linearity

WB Mode,
Neutrophil NEUT- - - - - - - -
granular GI
intensity
Hematopoietic HPC# - - - - - - -
precursor cell
number
Hematopoietic HPC% - - - - - - -
precursor cell
number ratio
Reticulocyte RET% - - - within ±20% or within ±20% or - 0.00- 30.00%
ratio ±0.30 RET% ±0.30 RET%
Reticulocyte RET# - - - within ±20% or within ±20% or - 0.00- 72.00 × 104/μL
count ±1.50 × 104/μL ±1.50 × 104/
μL
Immature IRF - - - - - - -
reticulocyte
fraction
Low LFR - - - - - - -
fluorescence
reticulocyte
ratio
Medium MFR - - - - - - -
fluorescence
reticulocyte
ratio
High HFR - - - - - - -
fluorescence
reticulocyte
ratio
Platelet count PLT-O 1) within ±7% 1) within 1) 0.0- 100.0 × 1) 2) within ±7% 1) 2) within - 1) 0.0- 100.0 × 104/μL
(RET or ±1.0 × 104/ ±15% or ±2.0 104/μL or ±1.0 × 104/μL ±15% or ±2.0 2) 100.1- 500.0 × 104/μL
channel) μL × 104/μL (Approx. 400 × × 104/μL
2) Fluctuation 104/μL in case
of PLT of RBC)
against the 2)
influence of 200<RBC<700
RBC is within ×104/μL
± 2.0 × 104/
μL
(In case of
PLT approx.
30.0 × 104/
μL)
Reticulocyte RET- - - - - - -
hemoglobin He
equivalent
Red blood cell RBC- - - - - - -
hemoglobin He
equivalent
Delta-He Delta- - - - - - -
He
HYPO-He HYPO - - - - - - -
-He
HYPER-He HYPE - - - - - - -
R-He
XN-1000/1500/2000 S/M 1-59 October 2018

Linearity

WB Mode,
Platelet count PLT-F 1) within ±5% 1) within 1) 0.0- 100.0 × 1) within ±5% or 1) 2) within - 1) 0.0- 100.0 × 104/μL
(PLT-F or ±1.0 × ±10% or ±2.0 104/μL ±1.0 × 104/μL ±10% or ±2.0 2) 100.1- 500.0 × 104/μL
channel) 104/μL × 104/μL (Approx. 400 × 2) within ±6% × 104/μL
2) Fluctuation 104/μL in case
of PLT of RBC)
against the 2)
influence of 200<RBC<700
RBC is within ×104/μL
± 2.0 × 104/
μL
(In case of
PLT approx.
30.0 × 104/
μL)
Immature IPF - - - - - - -
platelets ratio
Immature IPF# - - - - - - -
platelet count
White blood WBC- - - - - - Residual 1) 0.00- 0.50 × 102/µL
cell count BF and 2) 0.51- 100.00 × 102/µL
(Body fluid) residual When RBC is less than
rate against 100.0 × 104/µL
reference
(theoretical
value)
1) within
±0.10 ×
102/μL
2) within
±20%
Red blood cell RBC- - - - - - Residual 0.0- 500.0 × 104/µL
count BF and
(Body fluid) residual
rate against
reference
(theoretical
value)
±2% or
±1.0 × 104/
µL
Mononuclear MN# - - - - - - -
cell count
(Body fluid)
Polymorphon PMN# - - - - - - -
uclear cell
count
(Body fluid)
Mononuclear MN% - - - - - - -
cell ratio
(Body fluid)
Polymorphon PMN% - - - - - - -
uclear cell
ratio
(Body fluid)
XN-1000/1500/2000 S/M 1-60 October 2018

Linearity

WB Mode,
Total TC- - - - - - Residual 1) 0.00- 0.50 × 102/µL
nucleated cell BF# and 2) 0.51- 100.00 × 102/µL
count residual When RBC is less than
(Body fluid) rate against 100.0 × 104/µL
reference
(theoretical
value)
1) within
±0.10 ×
102/μL
2) within
±20%
Total TNC - - - - - - -
nucleated cell
count
White blood WBC- within ±3% or within ±10% 0.0- 1000.0 × 1) within ±3% or 1) 2) 3) within - 1) 0.0- 1000.0 × 102/μL
cell count N ±2.0 × 102/μL or ±4.0 × 102/ 102/μL ±2.0 × 102/μL ±10% or ±4.0 2) 1000.1- 3100.0 × 102/
(WNR μL 2) within ±6% × 102/μL μL
channel) 3) within ±11% 3) 3100.1- 4400.0 × 102/
μL
Total TNC-N - - - - - - -
nucleated cell
number
(WNR
channel)
White blood WBC- within ±3% or within ±10% 0.0- 1000.0 × 1) within ±3% or 1) 2) 3) within - 1) 0.0- 1000.0 × 102/μL
cell count D ±2.0 × 102/μL or ±4.0 × 102/ 102/μL ±2.0 × 102/μL ±10% or ±4.0 2) 1000.1- 3100.0 × 102/
(WDF μL 2) within ±6% × 102/μL μL
channel) 3) within ±11% 3) 3100.1- 4400.0 × 102/
μL
Total TNC-D - - - - - - -
nucleated cell
count
(WDF
channel)
White blood WBC- - - - - - - -
cell count P
(WPC
channel)
Total TNC-P - - - - - - -
nucleated cell
count
(WPC
channel)
Red blood cell RBC- - - - - - - -
count (RET O
channel)
- NEUT - - - - - - -
#&
- NEUT - - - - - - -
%&
- LYMP - - - - - - -
#&
- LYMP - - - - - - -
%&
- HFLC - - - - - - -
#
- HFLC - - - - - - -
%
XN-1000/1500/2000 S/M 1-61 October 2018

Linearity

WB Mode,
- AS- - - - - - - -
LYMP
%L
- RE- - - - - - - -
LYMP
%L
Basophils BA-N# - - - - - - -
count
(WNR
channel)
Basophil ratio BA- - - - - - - -
(WNR N%
channel)
Basophils BA-D# - - - - - - -
count
(WDF
channel)
Basophil ratio BA- - - - - - - -
(WDF D%
channel)
- NE- - - - - - - -
SSC
- NE- - - - - - - -
SFL
- NE- - - - - - - -
FSC
- LY-X - - - - - - -
- LY-Y - - - - - - -
- LY-Z - - - - - - -
- MO-X - - - - - - -
- MO-Y - - - - - - -
- MO-Z - - - - - - -
- NE- - - - - - - -
WX
- NE- - - - - - - -
WY
- NE- - - - - - - -
WZ
- LY-WX - - - - - - -
- LY-WY - - - - - - -
- LY-WZ - - - - - - -
- MO- - - - - - - -
WX
- MO- - - - - - - -
WY
- MO- - - - - - - -
WZ
- RET-Y - - - - - - -
- RET- - - - - - - -
RBC-Y
- IRF-Y - - - - - - -
- FRC# - - - - - - -
- FRC% - - - - - - -
Reticulocyte RPI - - - - - - -
production
index
XN-1000/1500/2000 S/M 1-62 October 2018

Linearity

WB Mode,
- RET- - - - - - - -
UPP
- RET- - - - - - - -
TNC
- H-IPF - - - - - - -
- HF- - - - - - - -
BF#
- HF- - - - - - - -
BF%
- NE- - - - - - - -
BF#
- NE- - - - - - - -
BF%
- LY- - - - - - - -
BF#
- LY- - - - - - - -
BF%
- MO- - - - - - - -
BF#
- MO- - - - - - - -
BF%
- EO- - - - - - - -
BF#
- EO- - - - - - - -
BF%
- RBC- - - - - - - -
BF2
XN-1000/1500/2000 S/M 1-63 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
sampling; Difference
(Human Stability Overtime Daily Voltage Temp.
Carryover average of between Blank
blood; (PD stability stability stability cycle
Parameter name 5 human Modules
average of 3 Mode: (Control (Control (Control (Control
blood
specimens, Human blood) blood) blood) blood)
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
White blood WBC 1.0%or within 5.0% within within within within within 5.0% within within ±5% 1.0 ×
cell count lower or 5.0 × 102/ 5.0% or 5.0% 10.0% 5.0% ±10.0% or ±4 × 102/μL
μL 5.0 × 102/ (After 72 102/μL or lower
μL hrs)
Red blood RBC 1.0% or within 3.0% within within within within within 3.0% within ±5.0% within ±3% 2 × 104/
cell count lower 3.0% 3.0% 5.0% 3.0% (After 72 or ±3 × μL or
hrs) 104/μL lower
Hemoglobin HGB 1.0% or within 3.0% within within within within within 3.0% within ±5.0% within ±3% 0.1g/dL
content lower 5.0% 3.0% 5.0% 3.0% (After 72 or ±0.3g/ or lower
hrs) dL
Hematocrit HCT 1.0% or within 3.0% within within within within within 3.0% within +5.0% within ±3% -
value lower (within 5.0 in 5.0% 3.0% 5.0% 3.0% (After 8 hrs) or ±0.3
case of within +8.0% HCT
control blood) (Cold
storage after
24 hrs)
within
+15.0%
(Storage at
18 to 26 °C
after 24 hrs)
Mean red MCV - - - - - - - within +5.0% - -
blood cell (After 8 hrs)
volume within +8.0%
(Cold
storage after
24 hrs)
within
+15.0%
(Storage at
18 to 26 °C
after 24 hrs)
Mean red MCH - - - - - - - - - -
blood cell
hemoglobin
content
Mean red MCHC - - - - - - - - - -
blood cell
hemoglobin
concentration
Platelet count PLT - - - - - - - - - -
Red blood RDW- - within 10.0% within within within within within - - -
cell SD 20.0% 10.0% 10.0% 10.0% 10.0%
distribution
width
Red blood RDW- - within 10.0% within within within within within - - -
cell CV 20.0% 10.0% 10.0% 10.0% 10.0%
distribution
width
XN-1000/1500/2000 S/M 1-64 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Micro Micro - - - - - - - within - -
erythrocyte R ±36.0% or
ratio ±2.0MicroR
(Storage at
18 to 26 °C
after 8 hrs)
(Cold
storage after
24 hrs)
Macro Macro - - - - - - - within - -
erythrocyte R ±36.0% or
ratio ±2.0MicroR
(Storage at
18 to 26 °C
after 8 hrs)
(Cold
storage after
24 hrs)
Platelet PDW - within 10.0% within within within within within - - -
distribution 20.0% 10.0% 10.0% 10.0% 10.0%
width
Mean platelet MPV - within 10.0% within within within within within - - -
volume 20.0% 10.0% 10.0% 10.0% 10.0%
Project life P-LCR - within 10.0% within within within within within - - -
coverage or 5.0 P-LCR 20.0% or 10.0% or 10.0% or 10.0% or 10.0% or
ratio 10.0 P- 5.0 P- 5.0 P-LCR 5.0 P- 5.0 P-LCR
LCR LCR LCR
Platelet crit PCT - within 10.0% within within within within within - - -
value 20.0% 10.0% 10.0% 10.0% 10.0%
Platelet count PLT-I 1.0% or within 10.0% within within within within within within ±10% within 1.0 ×
(PLT lower or 2.0 × 104/ 10.0% or 10.0% or 10.0% or 10.0% or 10.0% or or ±3.0 × ±7.0% or 104/μL
Channel) μL 2.0 × 104/ 2.0 × 104/ 2.0 × 104/ 2.0 × 104/ 2.0 × 104/μL 104/μL (After 4
±2.0 × 10 / or lower
μL μL μL μL 48 hrs) μL
Nucleated NRBC 2.0% or - - - - - - - - -
red blood cell # 0.2 × 102/
count μL or
lower
Nucleated NRBC - - - - - - - within within -
red blood cell % ±10.0% or ±20% or
ratio ±3.0/ ±2.0/
100WBC 100WBC
(After 24
hrs)
Neutrophil NEUT 2.0% or - - within within within within - - -
count # 0.5 × 102/ 15.0% 15.0% 10.0% 10.0%
μL or
lower
Lymphocyte LYMP 2.0% or - - within within within within - - -
count H# 0.5 × 102/ 15.0% 15.0% 10.0% 10.0%
μL or
lower
XN-1000/1500/2000 S/M 1-65 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Monocytes MONO 2.0% or - - within within within within - - -
count # 0.3 × 102/ 40.0% or 40.0% or 30.0% or 30.0% or
μL or 2.0 × 102/ 2.0 × 102/ 1.5 × 102/ 1.5 × 102/μL
lower μL μL μL
Eosinophil EO# 2.0% or - - within within within within - - -
count 0.3 × 102/ 15.0% or 15.0% or 10.0% or 10.0% or
μL or 1.5 × 102/ 1.5 × 102/ 1.0 × 102/ 1.0 × 102/μL
lower μL μL μL
Basophils BASO 2.0% or - - within within within within - - -
count # 0.3 × 102/ 15.0% or 15.0% or 10.0% or 10.0% or
μL or 1.0 × 102/ 1.0 × 102/ 0.8 × 102/ 0.8 × 102/μL
lower μL μL μL
Neutrophil NEUT - within 15.0% within - - - - within ±8.0 within ±5.0 -
ratio % 15.0% NEUT% NEUT%
(After 36
hrs) within
±8.0
NEUT%
(After 48
hrs)
Lymphocyte LYMP - within 15.0% within - - - - within ±7.0 within ±4.0 -
ratio H% 15.0% LYMPH% LYMPH%
(After 36
hrs)
within ±7.0
LYMPH%
(After 48
hrs)
Monocyte MONO - within 40.0% within - - - - within ±3.0 within ±3.0 -
ratio % or 2.0 40.0% or MONO% MONO%
MONO% 2.0 (After 36)
MONO% within ±4.0
MONO%
(After 48
hrs)
Eosinophil EO% - within 15.0% within - - - - within ±3.0 within ±2.0 -
ratio or 1.0 EO% 15.0% or EO% (After EO%
1.0 EO% 36 hrs)
within ±3.0
EO% (After
48 hrs)
Basophil ratio BASO - within 15.0% within - - - - within ±1.0 within ±1.0 -
% or 1.0 15.0% or BASO% BASO%
BASO% 1.0 (After 36
BASO% hrs)
±1.0
BASO%以内
(After 48
hrs)
Immature IG# - - - - - - - - - -
granulocyte
count
Immature IG% - - - - - - - within ±2.0 within ±2.0 -
granulocyte IG% (After IG%
ratio 24 hrs)
XN-1000/1500/2000 S/M 1-66 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
AS-LYMP# AS- - - - - - - - within - -
LYMP ±40.0%
# (After 24
hrs)
AS-LYMP% AS- - - - - - - - within ±5.0 - -
LYMP AS-LYMP%
% (After 24
hrs)
RE-LYMP# RE- - - - - - - - - - -
LYMP
#
RE-LYMP% RE- - - - - - - - within - -
LYMP ±30.0% or
% ±5.0 RE-
LYMP%
(After 24
hrs)
Neutrophil NEUT- - - - - - - - within ±8.0% - -
reactive RI (After 24
intensity hrs)
Neutrophil NEUT- - - - - - - - within ±8.0% - -
granular GI (After 24
intensity hrs)
Hematopoietic HPC# - - - - - - - - - -
precursor cell
number
Hematopoietic HPC% - - - - - - - - - -
precursor cell
number ratio
Reticulocyte RET% - within 20.0% within within within within within within within -
ratio or 0.30 20.0% or 20.0% or 20.0% or 20.0% or 20.0% or ±20.0% or 20.0% or
RET% 0.30 0.3 RET% 0.3 RET% 0.3 RET% 0.3 RET% ±0.3 RET% 0.3 RET%
RET% (After 24
hrs)
Reticulocyte RET# - within 20.0% within within within within within within within -
count or 1.50 × 104/ 20.0% or 20.0% or 20.0% or 20.0% or 20.0% or ±20.0% or 20.0% or
μL 1.50 × 1.5 × 104/ 1.5 × 104/ 1.5 × 104/ 1.5 × 104/μL ±1.5 × 104/ 1.5 × 104/
104/μL μL μL μL μL (After 24 μL
hrs)
Immature IRF - within 30.0% within within within within within within within -
reticulocyte or 10.0 IRF 30.0% or 30.0% or 30.0% or 30.0% or 30.0% or 30.0% or 30.0% or
fraction (within 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF
40.0IRF in (within (After 24
case of 40.0IRF in hrs)
control blood) case of
control
blood)
XN-1000/1500/2000 S/M 1-67 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Low LFR - within 30.0% within within within within within within within -
fluorescence or 10.0 LFR 30.0% or 30.0% or 30.0% or 30.0% or 30.0% or ±30.0% or 30.0% or
reticulocyte (within 35.0 10.0 LFR 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF ±10.0 LFR 10 LFR
ratio LFR in case (within (After 24
of control 35.0 LFR hrs)
blood) in case of
control
blood)
Medium MFR - within 30.0% within within within within within within within -
fluorescence or 10.0 MFR 30.0% or 30.0% or 30.0% or 30.0% or 30.0% or ±30.0% or 30.0% or
reticulocyte (within 30.0 10.0 MFR 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF ±10.0 LFR 10 LFR
ratio LFR in case (within (After 24
of control 30.0 LFR hrs)
blood) in case of
control
blood)
High HFR - within 30.0% within within within within within within 30.0% within -
fluorescence or 5.0 HFR 30.0% or 30.0% or 30.0% or 30.0% or 30.0% or or 5.0 HFR 30.0% or
reticulocyte (within 15.0 5.0 HFR 5.0 HFR 5.0 HFR 5.0 HFR 5.0 HFR (After 24 5.0 HFR
ratio LFR in case (within hrs)
of control 15.0 LFR
blood) in case of
control
blood)
Platelet count PLT-O 1.0% or within 13.0% within within within within within within within 1.0 ×
(RET lower or 2.0 × 104/ 13.0% or 13.0% 13.0% 13.0% 13.0% ±15.0% 20.0% 104/μL
channel) μL 2.0 × 104/ (After 48 or lower
μL hrs)
Reticulocyte RET- - - - - - - - within ±8.0% - -
hemoglobin He (however,
equivalent RET# 1.00 ×
104/μLor
higher)
(After 24
hrs)
Red blood RBC- - - - - - - - within ±8.0% - -
cell He (After 24
hemoglobin hrs)
equivalent
Delta-He Delta- - - - - - - - within RET- - -
He He ±8.0 and
within RBC-
He ±8.0%
(however,
RET# 1.00 ×
104/μLor
higher)
(After 24
hrs)
HYPO-He HYPO - - - - - - - - - -
-He
HYPER-He HYPE - - - - - - - - - -
R-He
XN-1000/1500/2000 S/M 1-68 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Platelet count PLT-F 1.0% or within 10.0% within within within within within within - 0.3 ×
(PLT-F lower or 2.0 × 104/ 10.0% or 10.0% or 10.0% or 10.0% or 10.0% or ±10.0% or 104/μL
channel) μL 2.0 × 104/ 2.0 × 104/ 2.0 × 104/ 2.0 × 104/ 2.0 × 104/μL ±3.0 × 104/ or lower
μL μL μL μL μL (After 48
hrs)
Immature IPF - - - - - - - within - -
platelets ratio ±30.0% or
2.0 IPF (PLT
10.0 × 104/
μL or higher,
IPF 2.0% or
higher)
(After 24
hrs)
Immature IPF# - - - - - - - within - -
platelet count ±30.0% or
±2.0 × 104/
μL (PLT 10.0
× 104/μL or
higher, IPF
2.0% or
higher)
(After 24
hrs)
White blood WBC- 0.3% or within 5.0% - within within - - - (not - 0.01 ×
cell count BF 0.01 × 5.0% 10.0% specified as 102/μL
(Body fluid) 102/μL or samples or lower
lower themselves
change after
collection)
Red blood RBC- 0.3% or within 3.0% - within within 5.0% - - - (not - 0.3 ×
cell count BF 0.3 × 104/ or 1.0 × 104/ 3.0% specified as 104/μL
(Body fluid) μL or μL samples or lower
lower themselves
change after
collection)
Mononuclear MN# - - - - - - - - (not - -
cell count specified as
(Body fluid) samples
themselves
change after
collection)
Polymorphon PMN# - - - - - - - - (not - -
uclear cell specified as
count samples
(Body fluid) themselves
change after
collection)
Mononuclear MN% - - - - - - - - (not - -
cell ratio specified as
themselves
change after
collection)
XN-1000/1500/2000 S/M 1-69 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Polymorphon PMN% - - - - - - - - (not - -
ratio samples
change after
collection)
Total TC- 0.3% or within 5.0% - within within - - - (not - -
nucleated cell BF# 0.01 × 5.0% 10.0% specified as
count 102/μL or samples
(Body fluid) lower themselves
change after
collection)
Total TNC - - - - - - - - - -
nucleated cell
count
White blood WBC- 1.0% or within 5.0% within within within within within 5.0% within within ±5% 1.0 ×
cell count N lower or 5.0 × 102/ 5.0% or 5.0% 10.0% 5.0% ±10.0% or ±4 × 102/μL
(WNR μL 5.0 × 102/ (After 72 2
10 /μL or lower
channel) μL hrs)
Total TNC-N - - - - - - - - - -
nucleated cell
number
(WNR
channel)
cell count D lower or 5.0 × 102/ 5.0% or 5.0% 10.0% 5.0% ±10.0% or ±4 × 102/μL
(WDF μL 5.0 × 102/ (After 72 102/μL or lower
channel) μL hrs)
Total TNC-D - - - - - - - - - -
nucleated cell
count
(WDF
channel)
White blood WBC- (In case of - - - - - - - - 1.0 ×
cell count P HPC 102/μL
(WPC Mode) or lower
channel) 0.5% or
lower
Total TNC-P - - - - - - - - - -
nucleated cell
count
(WPC
channel)
Red blood RBC- 1.5% or within 5.0% - - - - - - - -
cell count O lower
(RET
channel)
- NEUT - - - - - - - - - -
#&
- NEUT - - - - - - - - - -
%&
- LYMP - - - - - - - - - -
#&
XN-1000/1500/2000 S/M 1-70 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
- LYMP - - - - - - - - - -
%&
- HFLC - - - - - - - - - -
#
- HFLC - - - - - - - - - -
%
- AS- - - - - - - - - - -
LYMP
%L
- RE- - - - - - - - - - -
LYMP
%L
Basophils BA-N# - - - - - - - - - -
count
(WNR
channel)
(WNR N%
channel)
Basophils BA-D# - - - - - - - - - -
count
(WDF
channel)
(WDF D%
channel)
- NE- - - - - - - - - - -
SSC
- NE- - - - - - - - - - -
SFL
- NE- - - - - - - - - - -
FSC
- LY-X - - - - - - - - - -
- LY-Y - - - - - - - - - -
- LY-Z - - - - - - - - - -
- MO-X - - - - - - - - - -
- MO-Y - - - - - - - - - -
- MO-Z - - - - - - - - - -
- NE- - - - - - - - - - -
WX
- NE- - - - - - - - - - -
WY
- NE- - - - - - - - - - -
WZ
- LY-WX - - - - - - - - - -
- LY-WY - - - - - - - - - -
- LY-WZ - - - - - - - - - -
- MO- - - - - - - - - - -
WX
XN-1000/1500/2000 S/M 1-71 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
- MO- - - - - - - - - - -
WY
- MO- - - - - - - - - - -
WZ
- RET-Y - - - - - - - - - -
- RET- - - - - - - - - - -
RBC-Y
- IRF-Y - - - - - - - - - -
- FRC# - - - - - - - - - -
- FRC% - - - - - - - - - -
production
index
- RET- - - - - - - - - - -
UPP
- RET- - - - - - - - - - -
TNC
- H-IPF - - - - - - - - - -
- HF- - - - - - - - - - -
BF#
- HF- - - - - - - - - - -
BF%
- NE- - - - - - - - - - -
BF#
- NE- - - - - - - - - - -
BF%
- LY- - - - - - - - - - -
BF#
- LY- - - - - - - - - - -
BF%
- MO- - - - - - - - - - -
BF#
- MO- - - - - - - - - - -
BF%
- EO- - - - - - - - - - -
BF#
- EO- - - - - - - - - - -
BF%
- RBC- - - - - - - - - - -
BF2
XN-1000/1500/2000 S/M 1-72 October 2018

1. Analysis channel, Usage, Analysis mode, Precision,
Analysis range, Display range, Reportable Range (XN-11/ XN-21)
Note:
Research(*1): Performance guaranteed since it may become reportable
parameter as WBC or PLT.
Reportable
only)
White blood WBC WNR or Report Yes Yes - Yes × 10/μL (WB Mode)　 0.0- 9999.9 × 0.3- 4400.0 ×
cell count WDF able 0.04400.0 × 102/μL 102/μL 102/μL
(PD Mode)
0.0- 1000.0 × 102/μL
Red blood cell RBC RBC/ Report Yes Yes - Yes × 104/μL 0- 860 × 104/μL 0- 9999 × 104/ 1- 860 × 104/μL
count PLT able μL
Hemoglobin HGB HGB Report Yes Yes - Yes ・× 10(-1)g/dL 0.0- 26.0g/dL 0.0- 30.0g/dL 0.1- 26.0g/dL
content able ・× 10(-1)mmol/L 0.0- 16.14mmol/L 0.00-
18.62mmol/L
Hematocrit HCT RBC/ Report Yes Yes - Yes × 10(-1)% 0.0- 75.0% 0.0-100.0% 0.1- 75.0%
value PLT able
Mean red MCV RBC/ Report Yes Yes - Yes × 10(-1)fL - - -
blood cell PLT able
volume
Mean red MCH RBC/ Report Yes Yes - Yes ・× 10(-1)pg - - -
blood cell PLT, able ・amol
hemoglobin HGB
content
Mean red MCHC RBC/ Report Yes Yes - Yes ・× 10(-1)g/dL - - -
blood cell PLT, able ・× 10(-1)mmol/L
hemoglobin HGB
concentration
Platelet count PLT RBC/ Report Yes Yes - Yes × 103/μL - - -
PLT or able
RET or
PLT-F
Red blood cell RDW- RBC/ Report Yes Yes - Yes × 10(-1)fL - - -
distribution SD PLT able
width
Red blood cell RDW- RBC/ Report Yes Yes - Yes × 10(-1)% - - -
distribution CV PLT able
width
Platelet PDW RBC/ Resea Yes Yes - Yes × 10(-1)fL - - -
distribution PLT rch
width
Mean platelet MPV RBC/ Report Yes Yes - Yes × 10(-1)fL - - -
volume PLT able
Project life P-LCR RBC/ Resea Yes Yes - Yes × 10(-1)% - - -
coverage ratio PLT rch
Platelet crit PCT RBC/ Resea Yes Yes - Yes × 10(-2)% - - -
value PLT rch
Platelet count PLT-I RBC/ Resea Yes Yes - Yes × 103/μL (WB Mode) 0.0- 0.0- 999.9 × 0.2- 500.0 × 104/
(PLT Channel) PLT rch(*1) 500.0 × 104/μL 104/μL μL
(PD Mode) 0.0-
100.0 × 104/μL
Nucleated red NRBC WNR Report Yes Yes - Yes × 10/μL (WB Mode) 0.0- 0.0- 9999.9 × 0.1- 200.0 × 102/
blood cell # able 200.0 × 102/μL 102/μL μL
count
Nucleated red NRBC WNR Report Yes Yes - Yes × 10(-1)/100WBC (WB Mode) 0.0- 0.0- 9999.9/ 0.0- 600.0/
blood cell ratio % able 600.0/100WBC 100WBC 100WBC
Neutrophil NEUT WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
XN-1000/1500/2000 S/M 1-73 October 2018

Reportable
only)
Lymphocyte LYMP WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
count H# WNR able 102/μL
Monocytes MON WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
count O# WNR able 102/μL
Eosinophil EO# WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
count WNR able 102/μL
Basophils BASO WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
Neutrophil NEUT WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
ratio % WNR able
Lymphocyte LYMP WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
ratio H% WNR able
Monocyte ratio MON WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
O% WNR able
Eosinophil EO% WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
ratio WNR able
Basophil ratio BASO WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
% WNR able
Immature IG# WDF, Report Yes Yes - Yes × 10/μL - - 0.3- 4400.0 ×
granulocyte WNR able 102/μL
count
Immature IG% WDF, Report Yes Yes - Yes × 10(-1)% - - 0.0- 100.0%
granulocyte WNR able
ratio
Hematopoietic HPC# WPC(HP Report - - - Yes /μL - 0.00- 999.99 × -
precursor cell C mode) able 102/μL
number
Hematopoietic HPC% WPC(HP Resea - - - Yes × 10(-2)% - - -
precursor cell C mode) rch
number ratio
Reticulocyte RET% RET Report Yes Yes - Yes × 10(-2)% (WB Mode)0.00- 0.00- 99.99% 0.00- 30.00%
ratio able 30.00%
Reticulocyte RET# RET, Report Yes Yes - Yes × 10(-2)/μL (WB Mode)0.00- 0.00- 99.99 × 1.00- 72.00 ×
count RBC/ able 72.00 × 104/μL 104/μL 104/μL
PLT
Immature IRF RET Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0% 0.0-100.0%
reticulocyte able
fraction
Low LFR RET Resea Yes Yes - Yes × 10(-1)% - 0.0- 100.0% -
fluorescence rch
reticulocyte
ratio
Medium MFR RET Resea Yes Yes - Yes × 10(-1)% - 0.0- 100.0% -
fluorescence rch
reticulocyte
ratio
High HFR RET Resea Yes Yes - Yes × 10(-1)% - 0.0- 100.0% -
fluorescence rch
reticulocyte
ratio
Platelet count PLT-O RET Resea Yes Yes - Yes × 103/μL (WB Mode) 0.0- 0.0- 999.9×104/ -
(RET channel) rch(*1) 500.0 × 104/μL μL
(PD Mode) 0.0-
100.0 × 104/μL
Reticulocyte RET- RET Report Yes Yes - Yes ・× 10(-1)pg - -
equivalent
Platelet count PLT-F PLT-F Resea Yes Yes - Yes × 103/μL (WB Mode) 0.0- 999.9 × 0.2- 500.0 × 104/
(PLT-F rch(*1) 0.0- 500.0 × 104/μL 104/μL μL
channel) (PD Mode)
0.0- 100.0 × 104/μL
XN-1000/1500/2000 S/M 1-74 October 2018

Reportable
only)
Immature IPF PLT-F Report Yes Yes - Yes × 10(-1)% - 0.0- 100.0%
platelets ratio able
(*1)
Immature IPF# PLT-F Report Yes Yes - Yes × 102/μL - - -
platelet count able
White blood WBC- WDF (BF Report - - Yes - /μL 0.00- 100.00 × 102/ 0.00- 9999.99 × 0.03- 100.00 ×
cell count BF mode, able µL 102/μL 102/µL
(Body fluid) CSF
mode)
Red blood cell RBC- RBC (BF Report - - Yes - × 103/μL 0.0- 500.0 × 104/µL 0.0- 0.2- 500.0 × 104/
4
count BF mode) or able 9999.9×10 /μL µL
(Body fluid) RET
(CSF
mode)
Mononuclear MN# WDF (BF Report - - Yes - /μL - 0.00- 9999.99 × 0.03- 100.00 ×
cell count mode, able 102/μL 102/µL
(Body fluid) CSF
mode)
Polymorphonu PMN# WDF (BF Report - - Yes - /μL - 0.00- 9999.99 × 0.03- 100.00 ×
clear cell mode, able 102/μL 102/µL
count CSF
(Body fluid) mode)
Mononuclear MN% WDF(BF Report - - Yes - × 10(-1)% - 0.0- 100.0% / 0.0- 100.0%
cell ratio mode, able 0.000-
(Body fluid) CSF 1.000Ratio
mode)
Polymorphonu PMN WDF (BF Report - - Yes - × 10(-1)% - 0.0- 100.0% / 0.0- 100.0%
clear cell ratio % mode, able 0.000- 1.000
(Body fluid) CSF Ratio
mode)
Total TC- WDF (BF Report - - Yes - /μL 0.00-100.00×102/µL 0.03- 100.00 ×
nucleated cell BF# mode, able 102/µL
count CSF
(Body fluid) mode)
Total TNC WNR or Resea Yes Yes - Yes × 10/μL - 0.0- 9999.9 × -
nucleated cell WDF rch 102/μL
count
White blood WBC- WNR Resea Yes Yes - Yes × 10/μL (WB Mode) 0.0- 9999.9 × -
cell count N rch(*1) 0.0- 4400.0 × 102/μL 102/μL
(WNR (PD Mode)
channel) 0.0-1000.0 × 102/μL
Total TNC- WNR Resea Yes Yes - Yes × 10/μL - 0.0-9999.9 × -
nucleated cell N rch 102/μL
number
(WNR
channel)
White blood WBC- WDF Resea Yes Yes - Yes × 10/μL (WB Mode) 0.0- 9999.9 × -
cell count D rch(*1) 0.0-4400.0 × 102/μL 102/μL
(WDF (PD Mode)
channel) 0.0-1000.0 × 102/μL
Total TNC- WDF Resea Yes Yes - Yes × 10/μL - 0.0-9999.9 × -
nucleated cell D rch 102/μL
count
(WDF
channel)
White blood WBC- WPC Resea Yes - - Yes × 10/μL - 0.0-9999.9 × -
cell count P rch 102/μL
(WPC
channel)
XN-1000/1500/2000 S/M 1-75 October 2018

Reportable
only)
Total TNC- WPC Resea Yes - - Yes × 10/μL - 0.0- 9999.9 × -
nucleated cell P rch 102/μL
count
(WPC
channel)
Red blood cell RBC- RET Resea Yes Yes - Yes × 104/μL - 0- 9999 × 104/ -
count (RET O rch μL
channel)
Hemoglobin HGB- RET Resea Yes Yes - Yes ・× 10(-1)pg - - -
count (RET O rch ・× 10(-1)mmol/L
channel)
Micro Micro RBC/ Resea Yes Yes - Yes × 10(-1)% - - -
erythrocyte R PLT rch
ratio
Macro Macro RBC/ Resea Yes Yes - Yes × 10(-1)% - - -
erythrocyte R PLT rch
ratio
- NEUT WDF, Resea Yes Yes - Yes × 10/μL - - -
#& WNR rch
- NEUT WDF, Resea Yes Yes - Yes × 10(-1)% - - -
%& WNR rch
- LYMP WDF, Resea Yes Yes - Yes × 10/μL - - -
#& WNR rch
- LYMP WDF, Resea Yes Yes - Yes × 10(-1)% - - -
%& WNR rch
- HFLC WDF, Resea Yes Yes - Yes × 10/μL - - -
# WNR rch
- HFLC WDF, Resea Yes Yes - Yes × 10(-1)% - - -
% WNR rch
Basophils BA-N# WNR Resea Yes Yes - Yes × 10/μL - - -
count rch
(WNR
channel)
Basophil ratio BA- WNR Resea Yes Yes - Yes × 10(-1)% - - -
(WNR N% rch
channel)
Basophils BA-D# WDF, Resea Yes Yes - Yes × 10/μL - - -
count WNR rch
(WDF
channel)
Basophil ratio BA- WDF, Resea Yes Yes - Yes × 10(-1)% - - -
(WDF D% WNR rch
channel)
SSC rch
SFL rch
FSC rch
- LY-X WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- LY-Y WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- LY-Z WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- MO-X WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- MO-Y WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- MO-Z WDF Resea Yes Yes - Yes × 10(-1)ch - - -
rch
XN-1000/1500/2000 S/M 1-76 October 2018

Reportable
only)
WX rch
WY rch
WZ rch
- LY-WX WDF Resea Yes Yes - Yes None - - -
rch
- LY-WY WDF Resea Yes Yes - Yes None - - -
rch
- LY-WZ WDF Resea Yes Yes - Yes None - - -
rch
WX rch
WY rch
WZ rch
Red blood cell RBC- RET Resea Yes Yes - Yes ・× 10(-1)pg - - -
hemoglobin He rch ・amol
equivalent
- Delta- RET Resea Yes Yes - Yes ・× 10(-1)pg - - -
He rch ・amol
- RET-Y RET Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- RET- RET Resea Yes Yes - Yes × 10(-1)ch - - -
RBC- rch
Y
- IRF-Y RET Resea Yes Yes - Yes × 10(-1)ch - - -
rch
- FRC# RET, Resea Yes Yes - Yes × 102/μL - - -
RBC/ rch
PLT
- FRC% RET Resea Yes Yes - Yes × 10(-2)% - - -
rch
- HYPO RET Resea Yes Yes - Yes × 10(-1)ch - - -
-He rch
- HYPE RET Resea Yes Yes - Yes × 10(-1)ch - - -
R-He rch
Reticulocyte RPI RET, Resea Yes Yes - Yes None - - -
production RBC/ rch
index PLT
UPP rch
TNC rch
- PLT- PLT-F Resea Yes Yes - Yes × 102/μL
F2 rch
- H-IPF PLT-F Resea Yes Yes - Yes × 10(-1)% - - -
rch
- HF- WDF (BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- HF- WDF (BF Resea - - Yes - × 10(-1)/100WBC - - -
BF% mode, rch
CSF
mode)
- NE- WDF (BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
XN-1000/1500/2000 S/M 1-77 October 2018

Reportable
only)
- NE- WDF (BF Resea - - Yes - × 10(-1)% - - -
BF% mode, rch
CSF
mode)
- LY- WDF (BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- LY- WDF (BF Resea - - Yes - × 10(-1)% - - -
BF% mode, rch
CSF
mode)
- MO- WDF (BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- MO- WDF (BF Resea - - Yes - × 10(-1)% - - -
BF% mode, rch
CSF
mode)
- EO- WDF (BF Resea - - Yes - /μL - - -
BF# mode, rch
CSF
mode)
- EO- WDF (BF Resea - - Yes - × 10(-1)% - - -
BF% mode, rch
CSF
mode)
- RBC- RBC (BF Resea - - Yes - × 102/μL - - -
BF2 mode) or rch
RET(CS
F mode)
XN-1000/1500/2000 S/M 1-78 October 2018


White blood WBC XN XN CAL ICSH ・3.0% or 5.0% or - 40.0 × 102/μL or within ±3% or within -
cell count CHECK reference lower lower higher ±2.0 × 102/μL ±10%
method ・(Low
value
reference
at 15.0 ×
102/μL)
8.0% or
lower
・(Low
value
reference
at 5.0 ×
102/μL)
15.0% or
lower
Red blood cell RBC XN XN CAL ICSH 1.5% or 4.5% or - 400 × 104/μL or within ±2% or ±3 × within -
count CHECK reference lower lower higher 104/μL ±8%
method
Hemoglobin HGB XN XN CAL ICSH 1.0% or 3.0% or - - within ±2% or within -
content CHECK reference lower lower ±0.2g/dL ±5%
method
Hematocrit HCT XN XN CAL ICSH 1.5% or 4.5% or - - within ±3% or within -
value CHECK reference lower lower ±1.0 HCT ±4% or
method (however, within 8 ±2.0 HCT
hrs after blood (however
collection) , within 8
hrs after
blood
collection
)
Mean red MCV XN - (calculati 1.0% or 4.5% or - - within ±3% or within -
blood cell CHECK on: RBC, lower lower ±2.0fL (however, ±4% or
volume HCT) within 8 hrs after ±3.0fL
blood collection) (however
, within 8
hrs after
blood
collection
)
Mean red MCH XN - (calculati 2.0% or 4.5% or - - - - -
blood cell CHECK on: RBC, lower lower
hemoglobin HGB)
content
Mean red MCHC XN - (calculati 2.0% or 6.0% or - - - - -
blood cell CHECK on: HCT, lower lower
hemoglobin HGB)
concentration
Platelet count PLT PLT- PLT-I: XN ICSH - - - - - - -
I:XN CAL reference
CHECK PLT-O: method
PLT- XN CAL
O:XN PLT-F: XN
CHECK CAL PF
PLT-
F:XN
CHECK
distribution SD CHECK lower lower
width
XN-1000/1500/2000 S/M 1-79 October 2018


distribution CV CHECK lower lower
width
Platelet PDW XN - - - - - - - - -
distribution CHECK
width
Mean platelet MPV XN - - 4.0% or 8.0% or - - within ±5% or within -
volume CHECK lower lower ±1.0fL ±7% or
(PLT 10.0 × 104/μL ±1.5fL
or higher) (PLT
10.0 ×
104/μL or
higher)
Project life P-LCR XN - - - - - - - - -
coverage ratio CHECK
Platelet crit PCT XN - - - - - - - - -
value CHECK
Platelet count PLT-I XN XN CAL - ・4.0% or 12.0% or - 10.0 × 104/μL or within ±5% or ±1.0 within -
(PLT CHECK lower lower higher × 104/μL ±10%
Channel) ・(Low
value
reference
at 5.0 ×
104/μL)
8.0% or
lower
・(Low
value
reference
at 3 × 104/
μL) 10.0%
or lower
Nucleated red NRBC XN - SYSMEX 25.0% or 50.0% or - - - - -
blood cell # CHECK internal lower, or lower, or
(FCM) × 102/μL × 102/μL
Nucleated red NRBC XN - SYSMEX 25.0% or 50.0% or - WBC 40.0 × r ≥ 0.80 r ≥ 0.70 -
blood cell % CHECK internal lower, or lower, or 102/μL or higher
ratio method within ±1.5 within
(FCM) NRBC% ±3.0
NRBC%
Neutrophil NEUT XN - SYSMEX 8.0% or 16.0% or - 12.0 × 102/μL or - - -
method
(FCM)
Lymphocyte LYMP XN - SYSMEX 8.0% or 16.0% or - 6.0 × 102/μL or - - -
count H# CHECK internal lower lower higher
method
(FCM)
Monocytes MONO XN - SYSMEX 20.0% or 40.0% or - 2.0 × 102/μL or - - -
method
(FCM)
Eosinophil EO# XN - SYSMEX 25.0% or 40.0% or - - - - -
count CHECK internal lower, or lower
method within ±1.2
(FCM) × 102/μL
XN-1000/1500/2000 S/M 1-80 October 2018


Basophils BASO XN - SYSMEX 40.0% or 50.0% or - - - - -
count # CHECK internal lower, or lower, or
method within ±0.6 within
(FCM) × 102/μL ±0.6 × 102/
μL
Neutrophil NEUT XN - SYSMEX 8.0% or 16.0% or - 30.0 NEUT% or 1) r ≥ 0.90 1) r ≥ -
ratio % CHECK internal lower lower higher, 2) ±10% or within 0.70
method WBC 40.0 × ±3.0 NEUT% 2) within
NEUT%
Lymphocyte LYMP XN - SYSMEX 8.0% or 16.0% or - 15.0 LYMPH% 1) r ≥ 0.90 1) r ≥ -
ratio H% CHECK internal lower lower or higher, 2) ±10% or within 0.70
method WBC 40.0 × ±3.0 LYMPH% 2) within
LYMPH
%
Monocyte MONO XN - SYSMEX 20.0% or 40.0% or - 5.0 MONO% or 1) r ≥ 0.75 1) r ≥ -
ratio % CHECK internal lower lower higher, 2) ±10% or within 0.60
method WBC 40.0 × ±2.0 MONO% 2) within
MONO%
Eosinophil EO% XN - SYSMEX 25.0% or 40.0% or - WBC 40.0 × 1) r ≥ 0.80 1) r ≥ -
ratio CHECK internal lower, or lower 102/μL or higher 2) ±10% or within 0.60
method within ±1.5 ±1.0 EO% 2) within
(FCM) EO% ±1.0
EO%
Basophil ratio BASO XN - SYSMEX 40.0% or 50.0% or - WBC 40.0 × 1) r ≥ 0.50 1) r ≥ -
% CHECK internal lower, or lower, or 102/μL or higher 2) ±10% or within 0.50
method within ±1.0 within ±1.5 ±1.0 BASO% 2) within
(FCM) BASO% BASO% ±1.0
BASO%
Immature IG# XN - SYSMEX 25.0% or 75.0% or - IG# 1.0 × 102/ - - -
granulocyte CHECK internal lower, or lower or μL or higher
(FCM) × 102/μL × 102/μL
Immature IG% XN - SYSMEX 25.0% or 75.0% or - IG% 2.0% or 1) r ≥ 0.80 - -
granulocyte CHECK internal lower, or lower, or higher, 2) ±10% or within
ratio method within ±1.5 within WBC 40.0 × ±1.5 IG%
(FCM) IG% ±4.5 IG% 102/μL or higher
Hematopoietic HPC# XN - - 30.0% or - - - within ±30% or - -
precursor cell CHECK lower, or ±10/μL
number within ±15/
μL
precursor cell
number ratio
Reticulocyte RET% XN - Manual 15.0% or 35.0% or - RBC 300 × 104/ 1) r ≥ 0.90 1) r ≥ -
ratio CHECK method lower lower μL or higher, 2) within ±20% or 0.80
(CLSI RET% 1.00- ±0.30 RET% 2) within
H44-A2) 4.00% ±30% or
±0.50
RET%
Reticulocyte RET# XN - (calculati 15.0% or 35.0% or - RBC 300 × 104/ 1) r ≥ 0.90 1) r ≥ -
count CHECK on: lower lower μL or higher, 2) within ±20% or 0.80
RET%, RET% 1.00- ±1.50 × 104/μL 2) within
RBC) 4.00% ±30% or
±2.0 ×
104/μL
XN-1000/1500/2000 S/M 1-81 October 2018


Immature IRF XN - - 30.0% or - - RBC 300 × 104/ within ±30% or within -
reticulocyte CHECK lower μL or higher, ±10.0 IRF ±50% or
fraction RET% 1.00- (In case of control ±10.0
4.00%, IRF blood or calibrator, IRF
20.0% or higher within 40.0IRF)
Low LFR XN - - - - - - - - -
fluorescence CHECK
reticulocyte
ratio
Medium MFR XN - - - - - - - - -
fluorescence CHECK
reticulocyte
ratio
High HFR XN - - - - - - - - -
fluorescence CHECK
reticulocyte
ratio
Platelet count PLT-O XN XN CAL - 6.0% or 13.0% or - 10.0 × 104/μL or Within ±7% or Within -
(RET CHECK lower lower higher ±1.0 × 104/μL ±15%
channel)
Reticulocyte RET- XN - - 5.0% or - - RET# 2.00 × r ≥ 0.9 r ≥ 0.7 -
hemoglobin He CHECK lower 104/μL or higher (Including more
equivalent than half of
samples with RET
# 2.0 × 104 / μL or
more, out of the
entire number of
samples to be
analyzed)
Platelet count PLT-F XN XN CAL ICSH 1) 2.5% or 1) 5.0% or - 1) PLT 10.0 × Within ±5% or Within -
(PLT-F CHECK PF reference lower lower 104/μL or higher ±1.0 × 104/μL ±10%
channel) method 2) 5.0% or 2) 10.0% 2) PLT 2.0 ×
lower or lower 104/μL or higher
Immature IPF XN - - 1) 25.0% 40.0% or - 1) PLT 5.0 × r ≥ 0.8 r ≥ 0.5 -
platelets ratio CHECK or lower lower 104/μL or
2) higher, IPF
of 10.0% or higher
variation)
20.0% or
lower
Immature IPF# - - - - - - - - - -
platelet count
White blood WBC- XN Under Manual - - 1) 1) 0.05- 0.15 × - - r ≥ 0.9
cell count BF CHECK considerat method 30.0% 102/μL and the
(Body fluid) BF ion (CLSI or lower 2) 0.16- 0.30 × inclinati
H56-A) 2) 102/μL on of the
15.0% 3)0.31- 0.50 × regressi
or lower 102/μL on line
3)10.0% within 1
or lower ± 0.3
Red blood cell RBC- XN Under Manual - - 40.0% 0.3- 5.0 × 104/ - - r ≥ 0.8
count BF CHECK considerat method or lower μL and the
(Body fluid) BF ion (CLSI or inclinati
H56-A) Max-Min on of the
≤ 0.7 × regressi
104/μL on line
within
1±0.3
XN-1000/1500/2000 S/M 1-82 October 2018


Mononuclear MN# XN - Manual - - - - - - r ≥ 0.9
cell count CHECK method and the
H56-A) on of the
regressi
on line
within
1±0.5
Polymorphon PMN# XN - Manual - - - - - - r ≥ 0.9
count BF (CLSI inclinati
regressi
on line
within
1±0.5
Mononuclear MN% XN - Manual - - - - - - r ≥ 0.7
cell ratio CHECK method and the
H56-A) on of the
regressi
on line
within
1±0.5
Polymorphon PMN% XN - Manual - - - - - - r ≥ 0.7
ratio BF (CLSI inclinati
regressi
on line
within
1±0.5
Total TC- XN - - - - 1) 1) 0.05- 0.15 × - - r ≥ 0.9
nucleated cell BF# CHECK 30.0% 102/μL and the
count BF or lower 2) 0.16- 0.30 × inclinati
(Body fluid) 2)15.0% 102/μL on of the
or lower 3)0.31- 0.50 × regressi
3)10.0% 102/μL on line
or lower within
1±0.3
Total TNC - - - - - - - - - -
nucleated cell
count
White blood WBC- - - - ・3.0% or 5.0% or - 40.0 × 102/μL or Within ±3% or Within -
cell count N lower lower higher ±2.0 × 102/μL ±10%
(WNR ・(Low
channel) value
reference
at 15.0 ×
102/μL)
8.0% or
lower
・(Low
value
reference
at 5.0 ×
102/μL)
15.0% or
lower
XN-1000/1500/2000 S/M 1-83 October 2018


Total TNC-N - - - - - - - - - -
nucleated cell
number
(WNR
channel)
White blood WBC- XN XN CAL - ・3.0% or 5.0% or - 40.0 × 102/μL or Within ±3% or Within -
cell count D CHECK lower lower higher ±2.0 × 102/μL ±10%
(WDF ・(Low
channel) value
reference
at 15.0 ×
102/μL)
8.0% or
lower
・(Low
value
reference
at 5.0 ×
102/μL)
15.0% or
lower
Total TNC-D - - - - - - - - - -
nucleated cell
count
(WDF
channel)
White blood WBC- XN XN CAL - - - - - - - -
cell count P CHECK
(WPC
channel)
Total TNC-P - - - - - - - - - -
nucleated cell
count
(WPC
channel)
Red blood cell RBC- XN XN CAL - - - - - - - -
count (RET O CHECK
channel)
Hemoglobin HGB- - - - - - - - - - -
count (RET O
channel)
Micro Micro - - - - - - - - - -
erythrocyte R
ratio
Macro Macro - - - - - - - - - -
erythrocyte R
ratio
- NEUT - - - - - - - - - -
#&
- NEUT - - - - - - - - - -
%&
- LYMP - - - - - - - - - -
#&
- LYMP - - - - - - - - - -
%&
- HFLC - - - - - - - - - -
#
- HFLC - - - - - - - - - -
%
XN-1000/1500/2000 S/M 1-84 October 2018


Basophils BA-N# - - - - - - - - - -
count
(WNR
channel)
(WNR N%
channel)
Basophils BA-D# - - - - - - - - - -
count
(WDF
channel)
(WDF D%
channel)
- NE- - - - - - - - - - -
SSC
- NE- - - - - - - - - - -
SFL
- NE- - - - - - - - - - -
FSC
- LY-X - - - - - - - - - -
- LY-Y - - - - - - - - - -
- LY-Z - - - - - - - - - -
- MO-X - - - - - - - - - -
- MO-Y - - - - - - - - - -
- MO-Z - - - - - - - - - -
- NE- - - - - - - - - - -
WX
- NE- - - - - - - - - - -
WY
- NE- - - - - - - - - - -
WZ
- LY-WX - - - - - - - - - -
- LY-WY - - - - - - - - - -
- LY-WZ - - - - - - - - - -
- MO- - - - - - - - - - -
WX
- MO- - - - - - - - - - -
WY
- MO- - - - - - - - - - -
WZ
Red blood cell RBC- - - - - - - - - - -
hemoglobin He
equivalent
- Delta- - - - - - - - - - -
He
- RET-Y - - - - - - - - - -
- RET- XN XN CAL - - - - - - - -
RBC-Y CHECK
- IRF-Y - - - - - - - - - -
- FRC# - - - - - - - - - -
- FRC% - - - - - - - - - -
- HYPO - - - - - - - - - -
-He
- HYPE - - - - - - - - - -
R-He
XN-1000/1500/2000 S/M 1-85 October 2018


production
index
- RET- - - - - - - - - - -
UPP
- RET- - - - - - - - - - -
TNC
- PLT- - - - - - - - - - -
F2
- H-IPF - - - - - - - - - -
- HF- - - - - - - - - - -
BF#
- HF- - - - - - - - - - -
BF%
- NE- - - - - - - - - - -
BF#
- NE- - - - - - - - - - -
BF%
- LY- - - - - - - - - - -
BF#
- LY- - - - - - - - - - -
BF%
- MO- - - - - - - - - - -
BF#
- MO- - - - - - - - - - -
BF%
- EO- - - - - - - - - - -
BF#
- EO- - - - - - - - - - -
BF%
- RBC- - - - - - - - - - -
BF2
XN-1000/1500/2000 S/M 1-86 October 2018

Analysis Linearity
Linearity (IFU) Range
(IFU) Validation using stable substance
WB Condition
Standard
Mode, (WB Mode WB
Parameter name (WB Standard Standard PD Mode Body
Analysis Analysis HPC and PD Mode, PD
Mode, (PD (BF Fluid Condition
Range Range Mode Mode) HPC Mode
HPC Mode) Mode) Mode
Mode
Mode)
White blood WBC 1) within 1) within - 1) 0.0- (WB within within 0.0- 1) within 1) 2) 3) - 1) 0.0-
cell count ±3% or ±10% or 1000.0 × Mode) ±3% or ±10% or 1000.0 × ±3% or within 1000.0 ×
±2.0 × ±4.0 × 102/μL 0.0- ±2.0 × ±4.0 × 102/μL ±2.0 × ±10% or 102/μL
102/μL 102/μL 2) 4400.0 × 102/μL 102/μL 102/μL ±4.0 × 2) 1000.1-
2) within 1000.1- 102/μL 2) within 102/μL 3100.0 ×
±6 3100.0 × (PD ±6% 102/μL
3) within 102/μL Mode) 3) within 3) 3100.1-
±11 3) 0.0- ±11% 4400.0 ×
3100.1- 1000.0 × 102/μL
4400.0 × 102/μL
102/μL
Red blood cell RBC 1) within 1) 2) - 1) 0- 800 0- 860 × within within 0- 800 × within within - 0- 860 × 104/
count ±2% or within × 104/μL 104/μL ±2% or ±8% or 104/μL ±4% or ±8% or μL
±3 × 104/ ±8% or 2) 801- ±3 × 104/ ±6 × 104/ ±6 × ±6 ×
μL ±6 × 104/ 860 × μL μL 104/μL 104/μL
2) within μL 104/μL
±4% or
±6 × 104/
μL
Hemoglobin HGB 1) within 1) 2) - 1) 0.0- 0.0- within within 0.0- within within - 0.0- 26.0g/dL
content ±2% or within 25.0g/dL 26.0g/dL ±2% or ±5% or 25.0g/dL ±5% or ±5% or 0.0-
±0.2g/dL ±5% or 0.00- 0.0- ±0.2g/dL ±0.5g/dL 0.00- ±0.5g/dL ±0.5g/dL 16.14mmol/L
2) within ±0.5g/dL 15.52mm 16.14mm 15.52mm
±5% or ol/L ol/L ol/L
±0.5g/dL 2) 25.1-
26.0g/dL
15.53-
16.14mm
ol/L
Hematocrit HCT within within - 0.0- 0.0- within within 0.0- - - - -
value ±3% or ±4% or 75.0% 75.0% ±3% or ±4% or 75.0%
±1.0 HCT ±2.0 HCT ±1.0 HCT ±2.0 HCT
Mean red MCV - - - - - Fluctuati - 200<RBC - - - -
blood cell on of <700×104
volume MCV by /μL
RBC
concentr
ation is
within ±
2.0fL
Mean red MCH - - - - - - - - - - - -
blood cell
hemoglobin
content
Mean red blood MCHC - - - - - - - - - - - -
cell hemoglobin
concentration
Platelet count PLT - - - - - - - - - - - -
Red blood cell RDW- - - - - - Fluctuati - 200<RBC - - - -
distribution SD on of <700 ×
width RDW-SD 104/μL
by RBC
concentr
ation is
within
±3.0fL
XN-1000/1500/2000 S/M 1-87 October 2018

Analysis Linearity
WB Condition
Standard
Mode, (WB Mode WB
Mode
Mode)
Red blood cell RDW- - - - - - Fluctuati - 200<RBC - - - -
distribution CV on of <700 ×
width RDW-CV 104/μL
by RBC
concentr
ation is
within
±1.0
RDW-CV
Platelet PDW - - - - - - - - - - - -
distribution
width
Mean platelet MPV - - - - - - - - - - - -
volume
Project life P-LCR - - - - - - - - - - - -
coverage ratio
Platelet crit PCT - - - - - - - - - - - -
value
Platelet count PLT-I 1) within 1) within - 1) 0.0- (WB 1) within 1) within 1) 0.0- 1) within 1) 2) - 1) 0.0- 100.0
(PLT Channel) ±5% or ±10% or 100.0 × Mode) ±5% or ±10% or 100.0 × ±5% or within × 104/μL
±1.0 × ±2.0 × 104/μL 0.0- ±1.0 × ±2.0 × 104/μL ±1.0 × ±10% or 2) 100.1-
104/μL 104/μL 2) 100.1- 500.0 × 104/μL 104/μL (Approx. 104/μL ±2.0 × 500.0 × 104/
2) within 500.0 × 104/μL 2) PLT 400 × 104/ 2) within 104/μL μL
±6% 104/μL (PD fluctuatio μL in case ±6%
Mode) n within ± of RBC)
0.0- 2.0 × 2)
100.0 × 104/μL 200<RBC
104/μL against <700×104
the /μL
influence
of RBC
(Approx.
30.0 ×
104/μL in
case of
PLT )
Nucleated red NRBC# within - - 0.0- (WB - - - within within - 0.0- 200.0 ×
blood cell ±10% or 200.0 × Mode) ±10% or ±10% or 102/μL
count ±2.0 × 102/μL 0.0- ±2.0 × ±2.0 ×
102/μL 200.0 × 102/μL 102/μL
102/μL
Nucleated red NRBC within - - 0.0- (WB - - - within within - 0.0- 600.0/
blood cell ratio % ±20% or 600.0/ Mode) ±20% or ±20% or 100WBC
±2.0 100WBC 0.0- ±2.0 ±2.0
NRBC% 600.0/ NRBC% NRBC%
100WBC
Neutrophil NEUT# - - - - - - - - - - - -
count
Lymphocyte LYMPH - - - - - - - - - - - -
count #
Monocytes MONO - - - - - - - - - - - -
count #
Eosinophil EO# - - - - - - - - - - - -
count
Basophils BASO# - - - - - - - - - - - -
count
Neutrophil NEUT - - - - - - - - - - - -
ratio %
XN-1000/1500/2000 S/M 1-88 October 2018

Analysis Linearity
WB Condition
Standard
Mode, (WB Mode WB
Mode
Mode)
Lymphocyte LYMPH - - - - - - - - - - - -
ratio %
Monocyte ratio MONO - - - - - - - - - - - -
%
Eosinophil EO% - - - - - - - - - - - -
ratio
Basophil ratio BASO - - - - - - - - - - - -
%
Immature IG# - - - - - - - - - - - -
granulocyte
count
Immature IG% - - - - - - - - - - - -
granulocyte
ratio
Hematopoietic HPC# - - - - - - - - - - - -
precursor cell
number
Hematopoietic HPC% - - - - - - - - - - - -
precursor cell
number ratio
Reticulocyte RET% within within - (WB (WB - - - within within - 0.00- 30.00%
ratio ±20% or ±30% or Mode) Mode) ±20% or ±20% or
±0.30 ±0.50 0.00- 0.00- ±0.30 ±0.30
RET% RET% 30.00% 30.00% RET% RET%
Reticulocyte RET# within within - (WB (WB - - - within within - 0.00- 72.00 ×
count ±20% or ±30% or Mode) Mode) ±20% or ±20% or 104/μL
±1.50 × ±2.0 × 0.00- 0.00- ±1.50 × ±1.50 ×
104/μL 104/μL 72.00 × 72.00 × 104/μL 104/μL
104/μL 104/μL
Immature IRF - - - - - - - - - - - -
reticulocyte
fraction
Low LFR - - - - - - - - - - - -
fluorescence
reticulocyte
ratio
Medium MFR - - - - - - - - - - - -
fluorescence
reticulocyte
ratio
High HFR - - - - - - - - - - - -
fluorescence
reticulocyte
ratio
XN-1000/1500/2000 S/M 1-89 October 2018

Analysis Linearity
WB Condition
Standard
Mode, (WB Mode WB
Mode
Mode)
Platelet count PLT-O 1) 2) 1) within - 1) 0.0- (WB 1) within 1) within 1) 0.0- 1) 2) 1) 2) - 1) 0.0- 100.0
(RET channel) within ±15% or 100.0 × Mode) ±7% or ±15% or 100.0 × within within × 104/μL
±7% or ±2.0 × 104/μL 0.0- ±1.0 × ±2.0 × 104/μL ±7% or ±15% or 2) 100.1-
±1.0 × 104/μL 2) 100.1- 500.0 × 104/μL 104/μL (Approx. ±1.0 × ±2.0 × 500.0 × 104/
104/μL 500.0 × 104/μL 2) 400 × 104/ 104/μL 104/μL μL
104/μL (PD Fluctuati μL in case
Mode) on of PLT of RBC)
0.0- against 2)
100.0 × the 200<RBC
104/μL influence <700×104
of RBC is /μL
within ±
2.0 ×
104/μL
(In case
of PLT
approx.
30.0 ×
104/μL)
Reticulocyte RET- - - - - - - - - - - -
hemoglobin He
equivalent
Platelet count PLT-F 1) within 1) within - 1) 0.0- (WB 1) within 1) within 1) 0.0- 1) within 1) 2) - 1) 0.0- 100.0
(PLT-F ±5% or ±10% or 100.0 × Mode) ±5% or ±10% or 100.0 × ±5% or within × 104/μL
channel) ±1.0 × ±2.0 × 104/μL 0.0- ±1.0 × ±2.0 × 104/μL ±1.0 × ±10% or 2) 100.1-
104/μL 104/μL 2) 100.1- 500.0 × 104/μL 104/μL (Approx. 104/μL ±2.0 × 500.0 × 104/
2) ±6% 500.0 × 104/μL 2) 400 × 104/ 2) within 104/μL μL
104/μL (PD Fluctuati μL in case ±6%
Mode) on of PLT of RBC)
0.0- against 2)
100.0 × the 200<RBC
104/μL influence <700×104
of RBC is /μL
within ±
2.0 ×
104/μL
(In case
of PLT
approx.
30.0 ×
104/μL)
Immature IPF - - - - - - -
platelets ratio
Immature IPF# - - - - - - -
platelet count
White blood WBC- - - Residual 1) 0.00- 0.0- - - - - - Residual 1) 0.00- 0.50
cell count BF and 0.50 × 100.0 × and × 102/µL
(Body fluid) residual 102/µL 102/μL residual 2) 0.51-
rate 2) 0.51- rate 100.00 ×
against 100.00 × against 102/µL
reference 102/µL reference When RBC is
(theoretic When (theoretic less than
al value) RBC is al value) 100.0 × 104/
1) within less than 1) within µL
±0.10 × 100.0 × ±0.10 ×
102/μL 104/µL 102/μL
2) within 2) within
±20% ±20%
XN-1000/1500/2000 S/M 1-90 October 2018

Analysis Linearity
WB Condition
Standard
Mode, (WB Mode WB
Mode
Mode)
Red blood cell RBC- - - Residual 0.0- 0.0- - - - - - Residual 0.0- 500.0 ×
count BF and 500.0 × 500.0 × and 104/µL
(Body fluid) residual 104/μL 104/μL residual
rate rate
against against
reference reference
(theoretic (theoretic
al value) al value)
±2% or ±2% or
±1.0 × ±1.0 ×
104/µL 104/µL
Mononuclear MN# - - - - - - - - - - - -
cell count
(Body fluid)
Polymorphonu PMN# - - - - - - - - - - - -
clear cell count
(Body fluid)
Mononuclear MN% - - - - - - - - - - - -
cell ratio
(Body fluid)
Polymorphonu PMN% - - - - - - - - - - - -
clear cell ratio
(Body fluid)
Total nucleated TC-BF# - - Residual 1) 0.00- 0.0- - - - - - Residual 1) 0.00- 0.50
cell count and 0.50 × 100.0 × and × 102/µL
(Body fluid) residual 102/µL 102/μL residual 2) 0.51-
rate 2) 0.51- rate 100.00 ×
against 100.00 × against 102/µL
reference 102/µL reference When RBC is
(theoretic When (theoretic less than
al value) RBC is al value) 100.0 × 104/
1) within less than 1) within µL
±0.10 × 100.0 × ±0.10 ×
102/μL 104/µL 102/μL
2) within 2) within
±20% ±20%
Total nucleated TNC - - - - - - - - - - - -
cell count
White blood WBC-N 1) within 1) within - 1) 0.0- (WB within within 0.0- 1) within 1) 2) 3) - 1) 0.0-
(WNR ±2.0 × ±4.0 × 102/μL 0.0- ±2.0 × ±4.0 × 102/μL ±2.0 × ±10% or 102/μL
channel) 102/μL 102/μL 2) 4400.0 × 102/μL 2
10 /μL 102/μL ±4.0 × 2) 1000.1-
2) ±6% 1000.1- 102/μL 2) within 102/μL 3100.0 ×
3) ±11% 3100.0 × (PD ±6% 102/μL
102/μL Mode) 3) within 3) 3100.1-
3) 0.0- ±11% 4400.0 ×
3100.1- 1000.0 × 102/μL
4400.0 × 102/μL
102/μL
Total nucleated TNC-N - - - - - - - - - - - -
cell number
(WNR
channel)
XN-1000/1500/2000 S/M 1-91 October 2018

Analysis Linearity
WB Condition
Standard
Mode, (WB Mode WB
Mode
Mode)
White blood WBC-D 1) within 1) within - 1) 0.0- (WB within within 0.0- 1) within 1) 2) 3) - 1) 0.0-
(WDF channel) ±2.0 × ±4.0 × 102/μL 0.0- ±2.0 × ±4.0 × 102/μL ±2.0 × ±10% or 102/μL
102/μL 102/μL 2) 4400.0 × 102/μL 102/μL 102/μL ±4.0 × 2) 1000.1-
2) ±6% 1000.1- 102/μL 2) within 102/μL 3100.0 ×
3) ±11% 3100.0 × (PD ±6% 102/μL
102/μL Mode) 3) within 3) 3100.1-
3) 0.0- ±11% 4400.0 ×
3100.1- 1000.0 × 102/μL
4400.0 × 102/μL
102/μL
Total nucleated TNC-D - - - - - - - - - - - -
cell count
(WDF channel)
White blood WBC-P - - - - - - - - - - - -
cell count
(WPC
channel)
Total nucleated TNC-P - - - - - - - - - - - -
cell count
(WPC
channel)
Red blood cell RBC-O - - - - - - - - - - - -
count (RET
channel)
Hemoglobin HGB-O - - - - - - - - - - - -
count (RET
channel)
Micro MicroR - - - - - - - - - - - -
erythrocyte
ratio
Macro MacroR - - - - - - - - - - - -
erythrocyte
ratio
- NEUT# - - - - - - - - - - - -
&
- NEUT - - - - - - - - - - - -
%&
- LYMP# - - - - - - - - - - - -
&
- LYMP - - - - - - - - - - - -
%&
- HFLC# - - - - - - - - - - - -
- HFLC% - - - - - - - - - - - -
Basophils BA-N# - - - - - - - - - - - -
count
(WNR
channel)
Basophil ratio BA-N% - - - - - - - - - - - -
(WNR
channel)
Basophils BA-D# - - - - - - - - - - - -
count
(WDF channel)
Basophil ratio BA-D% - - - - - - - - - - - -
(WDF channel)
XN-1000/1500/2000 S/M 1-92 October 2018

Analysis Linearity
WB Condition
Standard
Mode, (WB Mode WB
Mode
Mode)
- NE- - - - - - - - - - - - -
SSC
- NE- - - - - - - - - - - - -
SFL
- NE- - - - - - - - - - - - -
FSC
- LY-X - - - - - - - - - - - -
- LY-Y - - - - - - - - - - - -
- LY-Z - - - - - - - - - - - -
- MO-X - - - - - - - - - - - -
- MO-Y - - - - - - - - - - - -
- MO-Z - - - - - - - - - - - -
- NE-WX - - - - - - - - - - - -
- NE-WY - - - - - - - - - - - -
- NE-WZ - - - - - - - - - - - -
- LY-WX - - - - - - - - - - - -
- LY-WY - - - - - - - - - - - -
- LY-WZ - - - - - - - - - - - -
- MO- - - - - - - - - - - - -
WX
- MO- - - - - - - - - - - - -
WY
- MO-WZ - - - - - - - - - - - -
Red blood cell RBC- - - - - - - - - - - - -
hemoglobin He
equivalent
- Delta- - - - - - - - - - - - -
He
- RET-Y - - - - - - - - - - - -
- RET- - - - - - - - - - - - -
RBC-Y
- IRF-Y - - - - - - - - - - - -
- FRC# - - - - - - - - - - - -
- FRC% - - - - - - - - - - - -
- HYPO- - - - - - - - - - - - -
He
- HYPER - - - - - - - - - - - -
-He
Reticulocyte RPI - - - - - - - - - - - -
production
index
- RET- - - - - - - - - - - - -
UPP
- RET- - - - - - - - - - - - -
TNC
- PLT-F2 - - - - - - - - - - - -
- H-IPF - - - - - - - - - - - -
- HF-BF# - - - - - - - - - - - -
- HF- - - - - - - - - - - - -
BF%
XN-1000/1500/2000 S/M 1-93 October 2018

Analysis Linearity
WB Condition
Standard
Mode, (WB Mode WB
Mode
Mode)
- NE- - - - - - - - - - - - -
BF#
- NE- - - - - - - - - - - - -
BF%
- LY-BF# - - - - - - - - - - - -
- LY- - - - - - - - - - - - -
BF%
- MO- - - - - - - - - - - - -
BF#
- MO- - - - - - - - - - - - -
BF%
- EO- - - - - - - - - - - - -
BF#
- EO- - - - - - - - - - - - -
BF%
- RBC- - - - - - - - - - - - -
BF2
XN-1000/1500/2000 S/M 1-94 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
White blood WBC 1.0% or within 5.0% within within within within within 5.0% within within ±5% 1.0 ×
cell count lower or 5.0 × 102/ 5.0% or 5.0% 10.0% 5.0% ±10.0% or ±4 × 102/μL
μL 5.0 × 102/ (After 72 102/μL or lower
μL hrs)
Red blood RBC 1.0% or within 3.0% within within within within within 3.0% within ±5.0% within ±3% 2 × 104/
cell count lower 3.0% 3.0% 5.0% 3.0% (After 72 or ±3 × μL or
hrs) 104/μL lower
Hemoglobin HGB 1.0% or within 3.0% within within within within within 3.0% within ±5.0% within ±3% 0.1g/dL
content lower 5.0% 3.0% 5.0% 3.0% (After 72 or ±0.3g/ or lower
hrs) dL
Hematocrit HCT 1.0% or within 3.0% within within within within within 3.0% within +8.0% within ±3% -
value lower (within 5.0 in 10.0% 3.0% 5.0% 3.0% (Storage at 2 or ±0.3
case of to 8 °C after HCT
control blood) 48 hrs)
within
+8.0%
(Storage at
18 to 26 °C
after 48 hrs)
Mean red MCV - - - - - - - within +8.0% - -
blood cell (Storage at 2
volume to 8 °C after
48 hrs)
within
+8.0%
(Storage at
18 to 26 °C
after 48 hrs)
Mean red MCH - - - - - - - within - -
blood cell ±8.0%
hemoglobin (Storage at
content 18 to 26 °C
after 24 hrs)
within
±8.0%
(Storage at 2
to 8 °C after
48 hrs)
Mean red MCHC - - - - - - - within - -
blood cell ±8.0%
hemoglobin (Storage at
concentration 18 to 26 °C
after 24 hrs)
within
±8.0%
(Storage at 2
to 8 °C after
48 hrs)
Platelet count PLT - - - - - - - - - -
XN-1000/1500/2000 S/M 1-95 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Red blood RDW- - within 25.0% within within within within within within - -
cell SD 50.0% 10.0% 10.0% 10.0% 10.0% ±15.0%
distribution (Storage at
width 18 to 26 °C
after 24 hrs)
within
±15.0%
(Storage at 2
to 8 °C after
48 hrs)
Red blood RDW- - within 25.0% within within within within within within - -
cell CV 50.0% 10.0% 10.0% 10.0% 10.0% ±10.0%
distribution (Storage at
width 18 to 26 °C
after 24 hrs)
within
±10.0%
(Storage at 2
to 8 °C after
48 hrs)
Platelet PDW - - - - - - - - - -
distribution
width
Mean platelet MPV - within 10.0% within within within within within within - -
volume 20.0% 10.0% 10.0% 10.0% 10.0% ±10.0%
(Storage at
18 to 26 °C
after 24 hrs)
within
±10.0%
(Storage at 2
to 8 °C after
48 hrs)
Project life P-LCR - - - - - - - - - -
coverage
ratio
Platelet crit PCT - - - - - - - - - -
value
Platelet count PLT-I 1.0% or within 10.0% within within within within within within ±10% within 1.0 ×
(PLT lower or 2.0 × 104/ 10.0% or 10.0% or 10.0% or 10.0% or 10.0% or or ±3.0 × ±7.0% or 104/μL
Channel) μL 2.0 × 104/ 2.0 × 104/ 2.0 × 104/ 2.0 × 104/ 2.0 × 104/μL 104/μL (After ±2.0 × 104/ or lower
μL μL μL μL 48 hrs) μL
Nucleated NRBC 2.0% or - - - - - - - - -
red blood cell # 0.2 × 102/
count μL or
lower
XN-1000/1500/2000 S/M 1-96 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Nucleated NRBC - - - - - - - within within -
red blood cell % ±10.0% or ±20% or
ratio ±3.0/ ±2.0/
100WBC 100WBC
(After 24
hrs)
within
±10.0% or
±3.0/
100WBC
(Storage at 2
to 8 °C after
48 hrs)
Neutrophil NEUT 2.0% or - - within within within within - - -
count # 0.5 × 102/ 15.0% 15.0% 10.0% 10.0%
μL or
lower
Lymphocyte LYMP 2.0% or - - within within within within - - -
count H# 0.5 × 102/ 15.0% 15.0% 10.0% 10.0%
μL or
lower
Monocytes MONO 2.0% or - - within within within within - - -
count # 0.3 × 102/ 40.0% or 40.0% or 30.0% or 30.0% or
μL or 2.0 × 102/ 2.0 × 102/ 1.5 × 102/ 1.5 × 102/μL
lower μL μL μL
Eosinophil EO# 2.0% or - - within within within within - - -
count 0.3 × 102/ 15.0% or 15.0% or 10.0% or 10.0% or
μL or 1.5 × 102/ 1.5 × 102/ 1.0 × 102/ 1.0 × 102/μL
lower μL μL μL
Basophils BASO 2.0% or - - within within within within - - -
count # 0.3 × 102/ 15.0% or 15.0% or 10.0% or 10.0% or
μL or 1.0 × 102/ 1.0 × 102/ 0.8 × 102/ 0.8 × 102/μL
lower μL μL μL
Neutrophil NEUT - within 15.0% within - - - - within ±8.0 within ±5.0 -
ratio % 15.0% NEUT% NEUT%
(After 36
hrs) within
±8.0
NEUT%
(After 48
hrs)
Lymphocyte LYMP - within 15.0% within - - - - within ±7.0 within ±4.0 -
ratio H% 15.0% LYMPH% LYMPH%
(After 36
hrs)
within ±7.0
LYMPH%
(After 48
hrs)
XN-1000/1500/2000 S/M 1-97 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Monocyte MONO - within 40.0% within - - - - within ±3.0 within ±3.0 -
ratio % or 2.0 40.0% or MONO% MONO%
MONO% 2.0 (After 36)
MONO% within ±4.0
MONO%
(After 48
hrs)
Eosinophil EO% - within 15.0% within - - - - within ±3.0 within ±2.0 -
ratio or 1.0 EO% 15.0% or EO% (After EO%
1.0 EO% 36 hrs)
within ±3.0
EO% (After
48 hrs)
Basophil ratio BASO - within 15.0% within - - - - within ±1.0 within ±1.0 -
% or 1.0 15.0% or BASO% BASO%
BASO% 1.0 (After 36
BASO% hrs)
±1.0
BASO%(Aft
er 48 hrs)
Immature IG# - - - - - - - - - -
granulocyte
count
Immature IG% - - - - - - - within ±2.0 within ±2.0 -
granulocyte IG% (After IG%
ratio 24 hrs)
within ±2.0
IG%
(Storage at 2
to 8 °C after
48 hrs)
Hematopoietic HPC# - - - - - - - - - -
precursor cell
number
precursor cell
number ratio
Reticulocyte RET% - within 20.0% within within within within within within within -
ratio or 0.30 20.0% or 20.0% or 20.0% or 20.0% or 20.0% or ±20.0% or 20.0% or
RET% 0.30 0.3 RET% 0.3 RET% 0.3 RET% 0.3 RET% ±0.3 RET% 0.3 RET%
RET% (After 24
hrs)
within
±20.0% or
±0.3 RET%
(Storage at 2
to 8 °C after
48 hrs)
Reticulocyte RET# - within 20.0% within within within within within within within -
count or 1.50 × 104/ 20.0% or 20.0% or 20.0% or 20.0% or 20.0% or ±20.0% or 20.0% or
μL 1.50 × 1.5 × 104/ 1.5 × 104/ 1.5 × 104/ 1.5 × 104/μL ±1.5 × 104/ 1.5 × 104/
104/μL μL μL μL μL (After 24 μL
hrs)
XN-1000/1500/2000 S/M 1-98 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Immature IRF - within 30.0% within within within within within within within -
reticulocyte or 10.0 IRF 30.0% or 30.0% or 30.0% or 30.0% or 30.0% or ±30.0% or 30.0% or
fraction (within 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF 10.0 IRF ±10.0 LFR 10.0 IRF
40.0IRF in (within (After 24
case of 40.0IRF in hrs)
control blood) case of within
control ±30.0% or
blood) ±10.0 LFR
(Storage at 2
to 8 °C after
48 hrs)
Low LFR - - - - - - - - - -
fluorescence
reticulocyte
ratio
Medium MFR - - - - - - - - - -
fluorescence
reticulocyte
ratio
High HFR - - - - - - - - - -
fluorescence
reticulocyte
ratio
Platelet count PLT-O 1.0% or within 13.0% within within within within within within - 1.0 ×
(RET lower or 2.0 × 104/ 13.0% or 13.0% 13.0% 13.0% 13.0% ±15.0% 104/μL
channel) μL 2.0 × 104/ (After 48 or lower
μL hrs)
Reticulocyte RET- - - - - - - - within ±8.0% - -
hemoglobin He (however,
equivalent RET# 1.00 ×
104/μLor
higher)
(After 24
hrs)
within ±8.0%
(however,
RET# 1.00 ×
104/μLor
higher)
(Storage at 2
to 8 °C after
48 hrs)
Platelet count PLT-F 1.0% or within 10.0% within within within within within within - 0.3 ×
(PLT-F lower or 2.0 × 104/ 10.0% or 10.0% or 10.0% or 10.0% or 10.0% or ±10.0% or 104/μL
channel) μL 2.0 × 104/ 2.0 × 104/ 2.0 × 104/ 2.0 × 104/ 2.0 × 104/μL ±3.0 × 104/ or lower
μL μL μL μL μL (After 48
hrs)
XN-1000/1500/2000 S/M 1-99 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Immature IPF - - - - - - - within - -
platelets ratio ±30.0% or
2.0 IPF (PLT
10.0 × 104/
μL or higher,
IPF 2.0% or
higher)
(After 24
hrs)
within
±30.0% or
2.0 IPF (PLT
10.0 × 104/
μL or higher,
IPF 2.0% or
higher)
(Storage at 2
to 8 °C after
48 hrs)
Immature IPF# - - - - - - - within - -
platelet count ±30.0% or
±2.0 × 104/
μL (PLT 10.0
× 104/μL or
higher, IPF
2.0% or
higher)
(After 24
hrs)
White blood WBC- 0.3% or within 5.0% - within within - - - (not - 0.01 ×
cell count BF 0.01 × 5.0% 10.0% specified as 102/μL
(Body fluid) 102/μL or samples or lower
lower themselves
change after
collection)
Red blood RBC- 0.3% or within 3.0% - within within 5.0% - - - (not - 0.3 ×
cell count BF 0.3 × 104/ or 1.0 × 104/ 3.0% specified as 104/μL
(Body fluid) μL or μL samples or lower
lower themselves
change after
collection)
Mononuclear MN# - - - - - - - - (not - -
cell count specified as
themselves
change after
collection)
Polymorphon PMN# - - - - - - - - (not - -
count samples
change after
collection)
XN-1000/1500/2000 S/M 1-100 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Mononuclear MN% - - - - - - - - (not - -
cell ratio specified as
themselves
change after
collection)
Polymorphon PMN% - - - - - - - - (not - -
ratio samples
change after
collection)
Total TC- 0.3% or within 5.0% - within within - - - (not - -
nucleated cell BF# 0.01 × 5.0% 10.0% specified as
count 102/μL or samples
(Body fluid) lower themselves
change after
collection)
Total TNC - - - - - - - - - -
nucleated cell
count
cell count N lower or 5.0 × 102/ 5.0% or 5.0% 10.0% 5.0% ±10.0% or ±4 × 102/μL
(WNR μL 5.0 × 102/ (After 72 2
10 /μL or lower
channel) μL hrs)
Total TNC-N - - - - - - - - - -
nucleated cell
number
(WNR
channel)
cell count D lower or 5.0 × 102/ 5.0% or 5.0% 10.0% 5.0% ±10.0% or ±4 × 102/μL
(WDF μL 5.0 × 102/ (After 72 102/μL or lower
channel) μL hrs)
Total TNC-D - - - - - - - - - -
nucleated cell
count
(WDF
channel)
White blood WBC- (In case of - - - - - - - - 1.0 ×
cell count P HPC 102/μL
(WPC Mode) or lower
channel) 0.5% or
lower
Total TNC-P - - - - - - - - - -
nucleated cell
count
(WPC
channel)
Red blood RBC- 1.5% or within 5.0% - - - - - - - -
cell count O lower
(RET
channel)
XN-1000/1500/2000 S/M 1-101 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
Hemoglobin HGB- - - - - - - - - - -
count (RET O
channel)
Micro Micro - - - - - - - - - -
erythrocyte R
ratio
Macro Macro - - - - - - - - - -
erythrocyte R
ratio
- NEUT - - - - - - - - - -
#&
- NEUT - - - - - - - - - -
%&
- LYMP - - - - - - - - - -
#&
- LYMP - - - - - - - - - -
%&
- HFLC - - - - - - - - - -
#
- HFLC - - - - - - - - - -
%
Basophils BA-N# - - - - - - - - - -
count
(WNR
channel)
(WNR N%
channel)
Basophils BA-D# - - - - - - - - - -
count
(WDF
channel)
(WDF D%
channel)
- NE- - - - - - - - - - -
SSC
- NE- - - - - - - - - - -
SFL
- NE- - - - - - - - - - -
FSC
- LY-X - - - - - - - - - -
- LY-Y - - - - - - - - - -
- LY-Z - - - - - - - - - -
- MO-X - - - - - - - - - -
- MO-Y - - - - - - - - - -
- MO-Z - - - - - - - - - -
- NE- - - - - - - - - - -
WX
- NE- - - - - - - - - - -
WY
XN-1000/1500/2000 S/M 1-102 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
- NE- - - - - - - - - - -
WZ
- LY-WX - - - - - - - - - -
- LY-WY - - - - - - - - - -
- LY-WZ - - - - - - - - - -
- MO- - - - - - - - - - -
WX
- MO- - - - - - - - - - -
WY
- MO- - - - - - - - - - -
WZ
Red blood RBC- - - - - - - - - - -
cell He
hemoglobin
equivalent
- Delta- - - - - - - - - - -
He
- RET-Y - - - - - - - - - -
- RET- - - - - - - - - - -
RBC-Y
- IRF-Y - - - - - - - - - -
- FRC# - - - - - - - - - -
- FRC% - - - - - - - - - -
- HYPO - - - - - - - - - -
-He
- HYPE - - - - - - - - - -
R-He
production
index
- RET- - - - - - - - - - -
UPP
- RET- - - - - - - - - - -
TNC
- PLT- - - - - - - - - - -
F2
- H-IPF - - - - - - - - - -
- HF- - - - - - - - - - -
BF#
- HF- - - - - - - - - - -
BF%
- NE- - - - - - - - - - -
BF#
- NE- - - - - - - - - - -
BF%
- LY- - - - - - - - - - -
BF#
- LY- - - - - - - - - - -
BF%
XN-1000/1500/2000 S/M 1-103 October 2018

Stability
Overtime
stability
Temp.
after blood
Stability Temp.
blood
samples
Control blood)
(Stored at
blood)
18 to 26 °C
or 2 to 8 °C)
- MO- - - - - - - - - - -
BF#
- MO- - - - - - - - - - -
BF%
- EO- - - - - - - - - - -
BF#
- EO- - - - - - - - - - -
BF%
- RBC- - - - - - - - - - -
BF2
XN-1000/1500/2000 S/M 1-104 October 2018

Chapter 1 Specifications (DR) : Edition: 164

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Chapter 1 Specifications (DR) : Edition: 164

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Edition: 164

Chapter 1 Specifications [DR]

1.1 Name & Model ................................................................................................................................ 1

1.2 Definitions ....................................................................................................................................... 1

1.3 Configurations and System Extendability ....................................................................................... 2

1.4 Interface with Other Instruments..................................................................................................... 4

1.5 System Extendability (Peripherals) ................................................................................................. 6

1.6 System Extendability (Software) ..................................................................................................... 6

1.7 Intended Use .................................................................................................................................. 6

1.8 Analysis Principle............................................................................................................................ 7

1.9 Analysis Parameters ....................................................................................................................... 8

1.10 Analysis & Display Ranges........................................................................................................... 13

1.11 Reproducibility .............................................................................................................................. 13

1.12 Accuracy ....................................................................................................................................... 13

XN-1000/1500/2000 S/M October 2018

1.12.4 Blood Cell Classifications (NEUT%, LYMPH%, MONO%, EO%,

1.13 Linearity ........................................................................................................................................ 14

1.14 Carryover ...................................................................................................................................... 15

1.15 Stability ......................................................................................................................................... 15

1.16 Throughput ................................................................................................................................... 16

1.17 Reagent Consumption .................................................................................................................. 17

1.18 Traceability ................................................................................................................................... 18

1.20 Dimension and Weight.................................................................................................................. 18

1.21 Environmental Requirements ....................................................................................................... 18

1.22 Power Supply................................................................................................................................ 19

1.23 Safety Protection .......................................................................................................................... 19

1.24 Containers for Sample .................................................................................................................. 19

1.25 Analysis ........................................................................................................................................ 19

1.26 Rinse Sequence ........................................................................................................................... 20

1.27 Designed Life Time ....................................................................................................................... 20

1.28 Periodical Replacement ................................................................................................................ 20

1.29 Conditions of Storing .................................................................................................................... 21

XN-1000/1500/2000 S/M October 2018

1.30 System Extendability (Software) ................................................................................................... 22

1.31 XN-10/XN-20/XN-11/XN-21 Special Analysis Mode ..................................................................... 30

XN-1000/1500/2000 S/M October 2018

1.1 Name & Model

1.1.1 Common Name

1.1.2 Brand Name

XN-1000/1500/2000 S/M 1-1 October 2018

1.3.1 Analyzer Configurations

BF Select Select Select Select Select Select

Select Select Select Select Select Select

XN-1000/1500/2000 S/M 1-2 October 2018

1.3.2 Reagent Configurations

1.3.3 Control Blood and Calibrator

XN-1000/1500/2000 S/M 1-3 October 2018

XN-1000/1500/2000 S/M 1-4 October 2018

Operating System (OS) Windows 7 professional (32bit) English version.

XN-1000/1500/2000 S/M 1-5 October 2018

1.6 System Extendability (Software)

1.6.1 System Variations

1.6.2 Security soft (Option)

1.7 Intended Use

1.7.1 Intended Use

1.7.2 Average Number of Analysis

1.7.3 Special Mode Specifications

XN-1000/1500/2000 S/M 1-6 October 2018

&9 &9 &9