RANDOX DIRECT LDL CHOLESTEROL

K982529 · Randox Laboratories, Ltd. · MRR · Sep 11, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982529
• Device Name: RANDOX DIRECT LDL CHOLESTEROL
• Applicant: Randox Laboratories, Ltd.
• Product Code: MRR · Clinical Chemistry
• Decision Date: Sep 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vitro diagnostic reagent for use in the quantitative determination of LDL Cholesterol in serum and plasma. The method, an elimination enzymatic assay, does not require any sample preparation. Accurate measurement of LDL Cholesterol is of vital importance in therapies that focus on lipid reduction to prevent atherosclerosis or reduce its progress. Suitably qualified laboratory personnel under appropriate laboratory conditions must use this Test Kit.

Device Story

Direct LDL Cholesterol Test Kit; in vitro diagnostic reagent for quantitative measurement of LDL cholesterol in serum and plasma samples. Employs elimination enzymatic assay method; requires no sample preparation. Used in clinical laboratory settings by qualified personnel. Provides quantitative LDL cholesterol concentration values to assist healthcare providers in assessing lipid profiles, monitoring lipid-lowering therapies, and managing atherosclerosis risk.

Clinical Evidence

No clinical data provided in the document. Device is an in vitro diagnostic reagent; performance is typically established via analytical bench testing (accuracy, precision, linearity) in accordance with standard laboratory assay validation requirements.

Technological Characteristics

In vitro diagnostic reagent; elimination enzymatic assay principle. No sample preparation required. Designed for use with serum and plasma specimens. Manual or automated clinical chemistry analyzer compatibility.

Indications for Use

Indicated for the quantitative determination of LDL cholesterol in serum and plasma for patients requiring lipid monitoring to manage atherosclerosis risk. For use by qualified laboratory personnel.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 1 1998

Dr. P. Armstrong . Requlatory Affairs Randox Laboratories, Ltd. Ardmore, Diamond Road Crumlin, Co. Antrim, United Kingdom, BT29 4QY

K982529 Re : Direct LDL Cholesterol Test Kit Requlatory Class: I Product Code: MRR Dated: July 17, 1998 Received: July 20, 1998 . .

Dear Dr. Armstrong:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .

Sincerely yours,
Steven Gutman

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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5983529 510(k) Number (if known)

Device Name DIRECT LDL - CHOLESTEROL

## Indications For Use :

The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vitro diagnostic reagent for use in the quantitative determination of LDL Cholesterol in serum and plasma. The method, an elimination enzymatic assay, does not require any sample preparation.

Accurate measurement of LDL Cholesterol is of vital importance in therapies that focus on lipid reduction to prevent atherosclerosis or reduce its progress.

Suitably qualified laboratory personnel under appropriate laboratory conditions must use this Test Kit.

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

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. K983090