BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUN - 6 1997 Dr. P. Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, Diamond Road Crumlin Co, Antrim United Kingdom, BT29 4QY Re: K970735 Boehringer Mannheim Direct HDL-Cholesterol Regulatory Class: I Product Code: LBS Dated: January 20, 1997 Received: February 18, 1997 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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. {1} Page 2 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 (770) 488-7655. 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, 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 {2} Page 1 of 1 510(k) Number (if known) K963213-K970735 Device Name DIRECT HIGH DENSITY LIPOPROTEINS - CHOLESTEROL (HDL - C) ## Indications For Use : The Randox Laboratories Limited Direct HDL - C Test Kit is an *in vitro* diagnostic reagent for the quantitative determination of HDL - C in serum or plasma. This method measures HDL - C directly without the need for a separate precipitation step. An inverse relationship has been found to exist between HDL - C levels and the incidence of coronary heart disease (CHD). The importance of HDL - C as a risk factor for CHD is now recognised. This test kit must be used by suitably 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) OR Over-The-Counter Use (Optional format1-2-96)