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

Intended 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)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 9 2004

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. 55 Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY

Re: k041361

> Trade/Device Name: Tri- Level Cardiac Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 31, 2004 Received: September 2, 2004

Dear Dr. Armstrong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper MS, DVM.

Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name: Tri-Level Cardiac Control

Indications 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 applications, specifically cardiac monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1 ml final re-constituted volume.

The Randox Tri-Level Cardiac Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041361