RANDOX IMMUNOASSAY CONTROL

K040379 · Randox Laboratories, Ltd. · JJY · Jun 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040379
• Device Name: RANDOX IMMUNOASSAY CONTROL
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 16, 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 Immunoassays on clinical chemistry and Immunoassay systems.

Device Story

Randox Immunoassay Controls are lyophilized human serum-based materials provided at three constituent concentrations (Levels I, II, and III). Used in clinical laboratories to monitor the accuracy and precision of immunoassay and clinical chemistry systems. The product is reconstituted with distilled water before use. It contains 33 analytes, including hormones, tumor markers, and therapeutic drugs. Laboratory personnel use the controls to verify system performance; results are compared against assigned target values and ranges provided in the package insert. The device serves as a standard reference material to ensure diagnostic test reliability.

Clinical Evidence

No clinical data; bench testing only. Device is a quality control material used to verify analytical performance of immunoassay systems.

Technological Characteristics

Lyophilized human serum-based control material. Supplied in 5 ml vials for reconstitution with distilled water. Contains 33 analytes (e.g., AFP, PSA, TSH, Digoxin). Stability: 7 days at 2-8°C (reconstituted) or 4 weeks at -20°C. PSA stability: 2 days at 2-8°C. No electronic or software components.

Indications for Use

Indicated for use as quality control material for monitoring accuracy and precision in immunoassay laboratory testing. Intended for use by qualified laboratory personnel 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN 1 6 2004

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

k040379 Re:

Trade/Device Name: Assayed Immunoassay Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: May 11, 2004 Received: May 13, 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 r ou may, aterer, mains 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back 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 r rouse be actived a determination that your device complies with other requirements of the Act that I Dr Hao Intatutes and regulations administered by other Federal agencies. You must or any I edelar states and 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) I fills letter will anow you to begin maxicoang your and equivalence of your device to a legally premail.cr notication. The PDF interessification 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, II you desire specific miromation assisted of your device, please contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the In Viro Diagliostic Derroo Driaa by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may oodain other general 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.

Yean 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

K040379 510(k) Number:

Assayed Immunoassay Controls Device Name:

Indications For Use:

The Randox Laboratories Ltd. Immunoassay Controls (Levels I, II, and III) are based on The Trandox Laboratorios Ltd. Have been developed for the control of both accuracy and lyophilisou namin obram and applications, particularly Immunoassay analysis. The proofolon in similable at three constituent concentrations, Each level is available in a 5ml final re-constituted volume.

The Randox Assayed Immunoassay Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 C. Benner
Division Sign Off

**Division Sign-Off**

Office of In Vitro Diagno

510(k) K040379

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