RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged around the caduceus in a circular fashion. The logo is presented in black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 1 3 2003 Dr. Lynne Hamilton Regulatory Affairs Randox Laboratories, Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom BT29 40Y Re: k023763 > Trade/Device Name: Fructosamine, Frutosamine Calibrator, Fructosamine Controls Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP; JIT; JJX Dated: November 7, 2002 Received: November 8, 2002 Dear Dr. Hamilton: 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 Title 21, Code 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {1}------------------------------------------------ ## Page 2 - This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (800) 638-2041 or (301) 443-6597 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) NOT KNOWN Fructosamine, Fructosamine Calibrator, Fructosamine Controls Device Name 2.3763 ## Indications For Use : ## Fructosamine The Randox Laboratories Limited Fructosamine test kit is an in vitro diagnostic enzymatic assay for the quantitative determination of glycated protein (fructosamine) in human serum or plasma. Measurement of glycated serum protein is representative of the mean blood glucose levels over the preceding 2-3 weeks. For in vitro diagnostic use only. Jean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 10(k) Number. K023763 Fructosamine Calibrator For calibration of the Fructosamine assay. For in vitro diagnostic use only. Fructosamine Controls (Level 1 and Level 3) To monitor the performance of the Fructosamine assay. For in vitro diagnostic use only. (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)