RANDOX LIPID CONTROL

K022591 · Randox Laboratories, Ltd. · JJY · Aug 30, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022591
• Device Name: RANDOX LIPID CONTROL
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on Iyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume. The Randox Lipid Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

Randox Lipid Controls consist of lyophilized human serum provided at three distinct concentration levels. Used as quality control material in clinical chemistry laboratories to verify accuracy and precision of lipid monitoring assays. Reconstituted by laboratory personnel to 1ml or 3ml volumes. Serves as a reference standard to ensure clinical analyzer performance; helps clinicians maintain reliable diagnostic results for patient lipid profiles.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum; three constituent concentration levels; available in 1ml and 3ml reconstituted volumes. Class I medical device.

Indications for Use

Indicated for use as quality control material for monitoring accuracy and precision in clinical chemistry lipid 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. P. Armstrong Regulatory Affairs Randox Laboratories, Limited Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY

AUG 3 0 2002

Re: k022591

> Trade/Device Name: Randox Lipid Control Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Control Material Regulatory Class: I Product Code: JJY Dated: July 30, 2002 Received: August 5, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

Kozz 591

LIPID CONTROLS (Levels I, Il and III) Device Name

Indications For Use :

The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on Iyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K023591