SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping, curved shapes that resemble a bird in flight or a flowing ribbon. NOV 4 1998 Ms. Marcia J. Arentz Vice President - Operations Synermed® Inc. 1688 50th Avenue Montreal (Lachine) Quebec, Canada H8T 2V5 Re: K983304 Trade Name: IR750 Direct Bilirubin Reagent Requlatory Class: II Product Code: CIG Dated: September 18, 1998 Received: September 21, 1998 Dear Ms. Arentz: 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 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). 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 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 requlation (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 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. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 {1}------------------------------------------------ Page 2 This letter will allow you to beqin 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 requlation (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, "Misbrandinq 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/dsma/dsmamain.html". Sincerely yours, Steven Putman 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__________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): Device Name: Direct Bilirubin Reagent Kit Indications For Use: The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma. Bilirubin is a product of the catabolism of hemoglobin. Bilirubin is transported through the blood (bound to albumin) to the liver where it is conjugated with glucuronic acid to form the diglucuronide. The bilirubin, in its water soluble conjugated glucuronide form, enters the biliary system for excretion in the bile. Healthy subjects have virtually no detectable conjugated bilirubin. Elevated levels of serum conjugated bilirubin are observed in a variety of conditions including hepatocellular disease, biliary tract obstruction, and some conditions involved in bilirubin metabolism. ## (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) | <div>✓</div> | |---------------------------------------|--------------| |---------------------------------------|--------------| OR | Over-The-Counter Use (Optional Format 1-2-96) | | |-----------------------------------------------|--| |-----------------------------------------------|--| (Division Sign-Off) Division of Clinical | 510(k) Number | k983304 | |---------------|---------| |---------------|---------|