RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

K110534 · Randox Laboratories Limited · JJY · Jan 23, 2012 · Clinical Chemistry

Device Facts

• Record ID: K110534
• Device Name: RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3
• Applicant: Randox Laboratories Limited
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.

Device Story

Randox Liquid Cardiac Controls are multi-analyte quality control materials derived from human plasma, serum, and proteins. The product consists of three levels containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. Used in clinical laboratories to monitor the performance and accuracy of cardiac marker assays on various clinical chemistry and immunoassay systems. Preservative (sodium azide) is included. Human source material is tested and found nonreactive for HIV 1/2, HBsAg, and HCV. Healthcare providers use the controls to verify assay performance; results help ensure the reliability of patient diagnostic testing for cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only. Stability testing protocols and acceptance criteria for shelf life (24 months) and open vial stability (30 days) at 2-8°C were reviewed and found acceptable. Expected values are determined via multi-site laboratory analysis.

Technological Characteristics

Liquid, assayed quality control material containing cardiac markers (BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, Troponin T). Designed for use on clinical chemistry and immunoassay systems. No specific materials of construction, energy sources, or software algorithms described.

Indications for Use

Indicated for use as quality control material for clinical chemistry and immunoassay systems to monitor the precision of assays for BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. Intended for prescription use in professional 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.

Submission Summary (Full Text)

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

A. 510(k) Number:
k110534

B. Purpose for Submission:
New device

C. Measurand:
Multi-analyte quality control materials

D. Type of Test:
Not applicable.

E. Applicant:
Randox Laboratories Limited

F. Proprietary and Established Names:
Randox Liquid Cardiac Control Levels 1, 2, and 3

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660, Quality Control Material (Assayed and Unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJY - Multi-Analyte Control
4. Panel:
75 Clinical Chemistry

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H. Intended Use:

1. Intended use(s):

Refer to indications for use below.

2. Indication(s) for use:

The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.

3. Special conditions for use statement(s):

For in vitro diagnostic use. For prescription use only.

4. Special instrument requirements:

Values are listed in the package insert for several analyzers.

I. Device Description:

The Randox Liquid Cardiac Controls are prepared from human plasma, human serum, and human proteins. The controls contain the following analytes: BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. The product consists of three levels. Sodium azide is present as a preservative.

Human source material from which this product has been derived has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NONREACTIVE. FDA approved methods have been used to conduct these tests.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Liquicheck Cardiac Markers Plus Controls

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

k050537

3. Comparison with predicate:

| Item | Device (k110534) | Predicate (k050537) |
| --- | --- | --- |
| Indications for use | For use as a quality control material in clinical chemistry assays. | Same |
| Format | Liquid, ready for use | Same |
| Matrix | Human serum and plasma | Human serum |
| Analytes | BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T | BNP, Creatine Kinase (Total), CRP, Homocysteine, Digitoxin, NT-proBNP, CKMB, Myoglobin, Troponin I, Troponin T |
| Stability | Unopened
Store at 2-8°C until expiration date
Opened
2-8°C for 30 days | Unopened
Store at -20 to -70°C until expiration date
Opened
2-8°C for 20 days |
| Levels | 3 | Same |

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

None were referenced in the submission.

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

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

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Expected values for the Randox Liquid Cardiac Controls are determined by repeat analyses at a minimum of three laboratory sites for each control level. Pre-determined acceptance criteria for analyte recovery must be met for each control lot. Control assigned values are lot dependent and are listed in the lot-specific Cardiac Control value sheet.

## Stability

Stability testing protocols and acceptance criteria for the Randox Liquid Cardiac Controls were reviewed and found acceptable. The manufacturer claims an open vial stability of 30 days and a shelf life stability of 24 months at the recommended storage temperatures of 2-8°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

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

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Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The expected values are provided in the labeling for each specific lot.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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