InteliQ Cardiac Advance Control

Levels 1, 2, 3 and 4
Level 1 97311T
12016484 Level 1 6 x 3 mL
Level 2 97312T
12016485 Level 2 6 x 3 mL 2025-11-30 97310T Level 3 97313T
12016486 Level 3 6 x 3 mL
Level 4 97314T
12016487 Level 4 6 x 3 mL

https://www.myeinserts.com/97310T

INTENDED USE LIMITATIONS

InteliQ Cardiac Advance Control is intended for use as an assayed quality control serum to 1. This product should not be used past the expiration date.
monitor the precision of laboratory testing procedures for the analytes listed in this 2. This product is not intended for use as a standard.
package insert. 3. If there is evidence of microbial contamination or excessive turbidity in the product, discard
SUMMARY AND PRINCIPLE the tube.
The use of quality control materials is indicated as an objective assessment of the precision of 4. For Laboratory/Professional Use Only
methods and techniques in use and is an integral part of good laboratory practices. Multiple 5. Values may gradually decrease over the product shelf life for the following analyte:
levels of control are available to allow monitoring of the test system’s reliability. CK-MB Isoenzyme.
For customers in Germany: Quality control materials are required for assessment of laboratory WARNING
performance as described in the “Guideline for Quality Assurance of Medical Laboratory
Examinations following the German Medical Association” (Rili-BÄK regulation). Biological source material. Treat as potentially infectious.
REAGENT The human source material used to manufacture this product was tested as required by FDA
This product is prepared from human source material with added constituents of human and accepted methods. Tests results were non-reactive or negative for evidence of infection due to
animal origin, stabilizers and preservatives. This product is provided in liquid form Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV). This
for convenience. product may also contain other human source materials for which there are no approved tests. In
STORAGE AND STABILITY accordance with good laboratory practice, all human source material should be considered
This product will be stable until the expiration date when stored unopened at -20 to -70°C. potentially infectious and handled with the same precautions used with patient specimens.
Refrigerator Storage (All Instruments, Off-Board, 2 to 8°C):
This product will be stable as follows:
- All analytes: 10 days
Except: Warning
- Troponin I and Homocysteine: 5 days Contains 5-Chloro-2-methyl-3(2H)-isothiazolone, mixture with 2-methyl-3(2H)-isothiazolone
Instrument Storage (Siemens Atellica, On-Board, 2 to 8°C): Hazard (H) and Precautionary (P) Statements
This product will be stable as follows: H317 May cause an allergic skin reaction.
- All analytes: 10 days H412 Harmful to aquatic life with long lasting effects.
- Galectin-3 and Troponin T: No claim is made for expected values or the stability. P333+P313 If skin irritation or rash occurs: Get medical advice/attention.
This product is shipped under frozen conditions. P273 Avoid release to the environment.
PROCEDURE P501 Dispose of contents/container in accordance with local/ regional/ national/
This product should be treated the same as patient specimens and run in accordance with the international regulations.
instructions accompanying the instrument, kit, or reagent being used. P280 Wear protective gloves/protective clothing/eye protection/face protection.
This product can only be used following either instrument storage or refrigerator storage P302+P352 IF ON SKIN: Wash with plenty of soap and water.
procedure, but not a combination of both. Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
To Thaw the Product: SPECIFIC PERFORMANCE CHARACTERISTICS
If the product has been stored frozen, allow it to stand at room temperature (18 to 25°C) until it This product is a stabilized liquid product manufactured under rigid quality control standards. To
is completely thawed. Once thawed, gently invert the tube several times to ensure homogeneity. obtain consistent assay values, the control requires proper storage and handling as described.
Refrigerator Storage (All Instruments, Off-Board, 2 to 8°C): ASSIGNMENT OF VALUES
Before use, gently invert the tube several times to ensure homogeneity. Remove the cap and The mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts
place the product in the instrument for testing. Once testing is completed, promptly replace the (available separately) were derived from replicate analyses and are specific for this lot of
cap and return the product to refrigerator storage. For optimal analyte stability, minimize the product. Data from Unity™ Interlaboratory Program are included in the determination of some
time on-board the instrument and exposure to room temperature. ranges. The tests listed were performed by the manufacturer and/or independent laboratories
Instrument Storage (Siemens Atellica, On-Board, 2 to 8°C): using manufacturer supported reagents and a representative sampling of this lot of product. It is
Remove the cap and place the product in the instrument for testing. Store the product opened for recommended that each laboratory establish its own acceptable ranges and use those provided
the duration of the on-board stability claim. only as guides. Laboratory established ranges may vary from those listed during the life of this
Safety Precautions control. [Customers in Germany have to follow the requirements as described in the Rili-BÄK
• Caution should be used when handling this product to prevent splashing. Wear appropriate regulation.] Variations over time and between laboratories may be caused by differences in
eye/face protection when using this product to protect from splashes. laboratory technique, instrumentation and reagents, or by manufacturer test
• If, during the use of this device or as a result of its use, a serious incident occurs, please method modifications.
report it to Bio-Rad Laboratories and to your national health authority, as required.
• Dispose of any discarded materials in accordance with the requirements of your local Unity™ Interlaboratory Program is a proprietary Bio-Rad software program holding more than 2
waste management authorities. In the event of damage to packaging, contact the local billion QC data points from thousands of laboratories.
Bio-Rad Laboratories Sales Office or Bio-Rad Laboratories Technical Services.
INSTRUCTIONS FOR OBTAINING THE DATA CHARTS
To obtain the Data Charts use the checkboxes on the Customize My eInserts page to select your
chart items. You can View & Print your selections or Save Selections. Follow the directions on
this website to receive email notifications of insert updates. Alternate methods for receiving data
charts are available by contacting your local Bio-Rad Laboratories Office.
BARCODE LABELS
For some instruments, supplemental barcode labels may be available at https://blg.qcnet.com.
Ensure the product tube is clean and dry prior to applying the label.

Page 1 English • 2023-11 • 30027-00W-00

 InteliQ Cardiac Advance Control, Levels 1, 2, 3 and 4
ANALYTES
B-type Natriuretic Peptide (BNP) Digitoxin Myoglobin Troponin I
CK-MB Isoenzyme Galectin-3 N-terminal pro-Brain Natriuretic Peptide Troponin T
(NT-proBNP)
C-Reactive Protein (CRP) Homocysteine

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Bio-Rad
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© 2023 Bio-Rad Laboratories Inc. Printed in the USA

InteliQ is a trademark of Bio-Rad Laboratories in certain jurisdictions. Page 2 English • 2023-11 • 30027-00W-00