LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS

K050537 · Bio-Rad · JJY · Apr 27, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050537
• Device Name: LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek™ Cardiac Markers Plus Control, Liquichek™ Cardiac Markers Plus Control LT, and Liquichek™ Cardiac Markers Plus Control LT Low are intended for use as quality control serum to monitor the precision of laboratory testing procedures listing in the package insert.

Device Story

Liquichek™ Cardiac Markers Plus Control series are liquid, human serum-based quality control materials; used in clinical laboratories to monitor precision of diagnostic testing procedures for cardiac markers. Device contains human/animal-derived constituents, preservatives, and stabilizers. Laboratory personnel use the control to verify instrument performance by comparing measured values against expected ranges provided in the package insert. Stability is maintained via frozen storage (-20°C to -70°C) with an open-vial claim of 20 days at 2-8°C. The device does not perform diagnostic analysis itself but serves as a reference standard to ensure accuracy and reliability of clinical chemistry analyzers.

Clinical Evidence

Bench testing only. Stability studies were conducted to validate shelf life (3 years at -20°C to -70°C) and open-vial stability (20 days at 2-8°C). No clinical data was required or provided.

Technological Characteristics

Liquid, human serum-based control material. Contains human/animal-derived constituents, preservatives, and stabilizers. No sodium azide; contains broad-spectrum anti-microbial cocktail (<0.1% concentration). Storage: -20°C to -70°C. Open-vial stability: 20 days at 2-8°C.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for cardiac markers including BNP, Creatine Kinase, CRP, Homocysteine, Digitoxin, NT-proBNP, CK-MB, Myoglobin, Troponin I, and Troponin T.

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 (k040277)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k050537

B. Purpose for Submission:
Marketing of a laboratory control

C. Measurand:
B-type Natriuretic Peptide (BNP), Creatine Kinase (Total), C-Reactive Protein (CRP), Homocysteine, Digitoxin, N-terminal pro-B-type Natriuretic Peptide (NT-proBNP), CK-MB, Myoglobin, Troponin I, Troponin T

D. Type of Test:
The product is used as a quality control serum to monitor the precision of laboratory testing procedures.

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquichek™ Cardiac Markers Plus Control
Liquichek™ Cardiac Markers Plus Control LT
Liquichek™ Cardiac Markers Plus Control LT Low

G. Regulatory Information:
1. Regulation section:
21CRF862.1660 Quality control material (assayed and unassayed).
2. Classification:
Class I
3. Product code:
JJY

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4. Panel:
(75) Chemistry

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
Liquichek™ Cardiac Markers Plus Control, Liquichek™ Cardiac Markers Plus Control LT, and Liquichek™ Cardiac Markers Plus Control LT Low are intended for use as quality control serum to monitor the precision of laboratory testing procedures listing in the package insert.

3. Special conditions for use statement(s):
For Prescription Use Only

4. Special instrument requirements:
Values are listed in the package insert for several analyzers

I. Device Description:
Liquichek™ Cardiac Markers Plus Control, Liquichek™ Cardiac Markers Plus Control LT, and Liquichek™ Cardiac Markers Plus Control LT Low are prepared from human serum with added constituents of human and animal original, preservatives, and stabilizers. The controls are in liquid form.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Liquichek™ Cardiac Markers Control LT

2. Predicate 510(k) number(s):
k040277

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item or Characteristic | Device | Predicate |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Differences | | |
| --- | --- | --- |
| Item or Characteristic | Device | Predicate |
| Storage (Unopened) | -20°C to -70°C
Until expiration date | -20°C or colder
Until expiration date |
| :Open Vial Claim | All Analytes 20 days at 2-8°C | All Analytes 10 days, except NT-proBNP 5 days at 2-8°C |
| Analytes | Contains: B-type Natriuretic Peptide (BNP), Creatine Kinase (Total), C-Reactive Protein (CRP), Homocysteine, Digitoxin, N-terminal pro-B-type Natriuretic Peptide (NT-proBNP), CK-MB, Myoglobin, Troponin I, Troponin T | Contains: Homocysteine, Digitoxin, N-terminal pro-B-type Natriuretic Peptide (NT-proBNP), CK-MB Isoenzyme, Myoglobin, Troponin I, Troponin T

Does not contain: B-type Natriuretic Peptide (BNP), Creatine Kinase (Total), C-Reactive Protein (CRP), |

K. Standard/Guidance Document Referenced (if applicable):

None were referenced in the submission.

L. Test Principle:

NA

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

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b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

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.

Accelerated stability studies were performed to support shelf life of the product. Real time studies are on-going for the life of the product. The acceptance criterion is defined as T final being ± 10% T zero. The results are as follows:

Shelf life stability: 3 years at -20 to -70°C

Open vial stability: 20 days at 2 to 8°C

d. Detection limit:

Not Applicable

e. Analytical specificity:

Not Applicable

f. Assay cut-off:

Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not Applicable

b. Matrix comparison:

Not Applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not Applicable

b. Clinical specificity:

Not Applicable

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c. Other clinical supportive data (when a. and b. are not applicable):

Not Applicable

4. Clinical cut-off:

Not Applicable

5. Expected values/Reference range:

Not Applicable

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10 including warning statements for biological source material and treat as potential infectious.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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