DIRECT HDL-CHOLESTROL LIQUID

K982341 · Randox Laboratories, Ltd. · LBS · Jul 30, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982341
• Device Name: DIRECT HDL-CHOLESTROL LIQUID
• Applicant: Randox Laboratories, Ltd.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Jul 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Randox Liquid Direct HDL-Cholesterol (HDL-C) test kit is an in vitro diagnostic reagent for the quantitative determination of HDL-Cholesterol in human serum and plasma. Accurate measurement of HDL-C is of importance when assessing patient risk from coronary heart disease. In this diagnostic test kit a method for direct measurement of HDL-C, without sample pretreatment is presented. It is recommended that this test kit be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

Device Story

In vitro diagnostic reagent kit for direct measurement of HDL-Cholesterol in human serum and plasma; eliminates need for sample pretreatment. Used in clinical laboratory settings by qualified personnel. Provides quantitative results to assist healthcare providers in assessing patient risk for coronary heart disease.

Technological Characteristics

In vitro diagnostic reagent for quantitative chemical analysis. Liquid format. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the quantitative determination of HDL-Cholesterol in human serum and plasma to assess coronary heart disease 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jul 3 0 1998

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

K982341 Re : Direct HDL Cholesterol Requlatory Class: I Product Code: LBS Dated: June 19, 1998 Received: June 22, 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 requlations 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 Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.

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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 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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| 510(k) Number (if known) | UNKNOWN |
|--------------------------|--------------------------|
| Device Name | DIRECT HDL - CHOLESTEROL |
| | LIQUID |

## Indications For Use :

The Randox Liquid Direct HDL-Cholesterol (HDL-C) test kit is an in vitro diagnostic reagent for the quantitative determination of HDL-Cholesterol in human serum and plasma. Accurate measurement of HDL-C is of importance when assessing patient risk from coronary heart disease.

In this diagnostic test kit a method for direct measurement of HDL-C, without sample pretreatment is presented.

It is recommended that this test kit be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

(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)

(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional format 1-2-96)

Aberhart (for A. Montgomery)

inical Laboratory Devices