LIQUICHEK CARDIAC MARKER CONTROL LT

K040277 · Bio-Rad Laboratories, Inc. · JJY · Mar 10, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040277
• Device Name: LIQUICHEK CARDIAC MARKER CONTROL LT
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Liquichek Cardiac Markers Control LT is a liquid, human serum-based quality control material; contains human and animal-derived constituents, preservatives, and stabilizers. Used in clinical laboratories to monitor precision of testing procedures for cardiac markers including NT-proBNP, CK-MB, Digitoxin, Homocysteine, Myoglobin, Troponin I, and Troponin T. Provided as a multi-level product (Levels 1, 2, 3, and Low Level). Healthcare providers use the control to verify the accuracy and reliability of diagnostic assay performance; helps ensure consistent clinical decision-making by validating laboratory test results. Does not contain sodium azide; utilizes a broad-spectrum anti-microbial cocktail.

Clinical Evidence

No clinical data. Bench testing only; stability studies performed to determine shelf life (2 years at -20°C) and open vial stability (10 days at 2-8°C, except 5 days for NT-proBNP). Mean values derived from replicate analysis by manufacturer and/or independent laboratories.

Technological Characteristics

Human serum-based control; liquid form. Contains human/animal-derived constituents, stabilizers, and broad-spectrum anti-microbial preservatives (<0.1% concentration). Storage at -20°C or colder. Multi-level (1, 2, 3, and Low).

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for cardiac markers in clinical laboratory settings.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Liquichek™ Cardiac Markers Control LT (K021498)

Submission Summary (Full Text)

{0}

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k040277

B. Analyte:
CK-MB, Digitoxin, Homocysteine, Myoglobin, Troponin I, Troponin T, NT-proBNP

C. Type of Test:
Quality Control Material

D. Applicant:
Bio-Rad Laboratories

E. Proprietary and Established Names:
Liquichek™ Cardiac Markers Control LT

F. Regulatory Information:
1. Regulation section:
21 CFR 862.1660
2. Classification:
Class I
3. Product Code:
JJY
4. Panel:
75

G. Intended Use:
1. Indication(s) for use:
For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert
2. Special condition for use statement(s):
NA
3. Special instrument Requirements:
Values are listed for several analyzers

H. Device Description:
Liquichek Cardiac Markers Control LT are human serum based controls which are supplied frozen at levels 1, 2, 3 and low level. The product is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers and supplied in liquid form. Each level is supplied as 6 x 3 ml. vials. The vials are thawed at room temperature before use. Stability studies have been performed to determine the open vial stability and shelf life. The shelf life is 2 years

{1}

at -20° C. The open vial stability is 10 days at 2-8° C except for NT-proBNP. NT-proBNP is stable for 5 days at 2-8° C.

Page 2 of 3

## I. Substantial Equivalence Information:

1. Predicate device name(s):
Liquichek™ Cardiac Markers Control LT
2. Predicate K number(s):
k021498
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Liquichek Cardiac Markers LT K040277 | Liquichek Cardiac Markers LT K021498 |
| Intended use | Similar | Similar |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Storage | - 20 ° C or colder | - 20 ° C or colder |
| Differences | | |
| Item | Liquichek Cardiac Markers LT K040277 | Liquichek Cardiac Markers LT K021498 |
| Number of levels | 1, 2, 3, and low level | 1, 2, and 3 (does not contain low level) |
| Analytes | NT-proBNP, CK-MB, digitoxin, homocysteine, myoglobin, troponin I, troponin T | CK-MB, digitoxin, homocysteine, myoglobin, troponin I, troponin T
Does not contain NT-proBNP |

## J. Standard/Guidance Document Referenced (if applicable):

None referenced

## K. Test Principle:

NA

## L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
NA

b. Linearity/assay reportable range:
NA

c. Traceability (controls, calibrators, or method):
The mean values were derived from replicate analysis. The tests listed in the labeling were performed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents.

{2}

Page 3 of 3

d. Detection limit: NA
e. Analytical specificity: NA
f. Assay cut-off: NA

2. Comparison studies:
a. Method comparison with predicate device: NA
b. Matrix comparison: NA

3. Clinical studies:
a. Clinical sensitivity: NA
b. Clinical specificity: NA
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off: NA

5. Expected values/Reference range: NA

M. Conclusion:
Based upon a review of the information presented in this submission, I recommend that this device is substantially equivalent to devices regulated by 862.1660, Multi-Analyte Controls, All Kinds (assayed and unassayed); 75 JJY, Class I.