RANDOX TRI LEVEL CARDIAC CONTROL

K041361 · Randox Laboratories Limited · JJY · Sep 9, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041361
• Device Name: RANDOX TRI LEVEL CARDIAC CONTROL
• Applicant: Randox Laboratories Limited
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

This product is intended for in vitro diagnostic use in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

Device Story

Tri-Level Cardiac Control consists of lyophilized human serum provided at three distinct constituent concentrations; used as quality control material to monitor accuracy and precision of clinical chemistry cardiac assays. Product is reconstituted to 1 ml volume by laboratory personnel; utilized in clinical laboratory settings to validate assay performance. Provides reference points for clinicians to verify cardiac monitoring test results; ensures reliability of diagnostic data used in clinical decision-making.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum; three constituent concentration levels; 1 ml reconstituted volume. Class I device under 21 CFR 862.1660.

Indications for Use

Indicated for use by qualified laboratory personnel for quality control of accuracy and precision in clinical chemistry cardiac monitoring applications. Available in three constituent concentrations (levels I, II, and III) based on lyophilized human serum.

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)

{0}

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

A. 510(k) Number: k041361

B. Purpose of Submission: Premarket Notification [510(k)] of intention to manufacture and market a Tri-Level Cardiac Control

C. Analyte: Multi Analyte Control: Total CK, CK-MB activity, CK-MB mass, homocysteine, myoglobin, troponin I, and troponin T.

D. Type of Test: NA

E. Applicant: Randox Laboratories Ltd.

F. Proprietary and Established Names: Randox Tri-Level Cardiac Control

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
4. Panel: 75

H. Intended Use:

1. Intended use(s): This product is intended for in vitro diagnostic use in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.

2. Indication(s) for use: The Randox Laboratories Ltd. Tri-Level Cardiac Control (level I, II and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry application, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 mL final re-constituted volume.

3. Special condition for use statement(s): The Randox Laboratories Tri-Level Cardiac Controls should be used bu suitable qualified laboratory personnel under appropriate laboratory conditions.

{1}

Page 2 of 3

4. Special instrument Requirements: The Randox Tri-Level Control can be used with a range of assays in a variety of Chemistry Analyzers. The specific assays and analyzers are listed in the package insert.

I. Device Description: The control contains human based lyophilized sera supplied at 3 levels. 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 NON-REACTIVE. FDA approved methods have been used to conduct these tests. However, this material should be handled as though capable of transmitting infectious diseased and disposed accordingly.

J. Substantial Equivalence Information:

1. Predicate device name(s): Liquichek™ Cardiac Markers Control Levels 1, 2 and 3 by Bio-Rad
3. Predicate K number(s): k021498
4. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Randox Tri Level Cardiac Control | Predicate: Liquichek Cardiac Markers LT K021498 |
| Intended use | Similar | Similar |
| Matrix | Human serum based | Human serum based |
| Number of Levels | 3 | 3 |
| Differences | | |
| Item | Randox Tri Level Cardiac Control | Liquichek Cardiac Markers LT K021498 |
| Analytes | Total CK, CK-MB activity, CK-MB mass, homocysteine, myoglobin, troponin I, troponin T | CK-MB, digitoxin, homocysteine, myoglobin, troponin I, troponin T |
| Form | Lyophilized | Liquid |
| Storage | Refrigerated 4 °C | -20 °C or colder |

K. Standard/Guidance Document Referenced (if applicable): None referenced.

L. Test Principle: NA

{2}

Page 3 of 3

# M. 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 analytes are not traceable to Standards. Values are assigned from a consensus of a number of laboratories (4 to 43- depending on the analyte and method) and for CK-MB and myoglobin also from in house testing using Randox methods against a master lot of controls on a Hitachi 911 and AU400 (CK-MB) and a Hitachi 717 (myoglobin).

Real time stability was performed and all values must meet the Randox acceptance criteria. Stability of reconstituted controls was also performed at 4 °C and 25 °C and the product labeled accordingly.

c. Detection limit: NA
d. Analytical specificity: NA
e. 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): NA

4. Clinical cut-off: NA
5. Expected values/Reference range: NA

# N. Conclusion:

The submitted material in this premarket notification is complete and supports a substantially equivalence decision.