BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUN 3 1008 Karen Callbeck, R.T.B.Sc. Requlatory Affairs Coordinator Diagnostic Chemicals Limited 16 First Street West Royalty Industrial Park Charlottetown, P.E.I. Canada C1E, 1B0 K981609 Re : Bilirubin-SL (Direct) Assay Catalogue No. 247-10, 247-30 Regulatory Class: II Product Code: CIG Dated: April 21, 1998 May 5, 1998 Received: : Dear Ms. Callbeck: 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 aqainst 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 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 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 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 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 Litman 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}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Bilirubin-SL (Direct) Assay ## Indications for Use: For the quantitative determination of in Bilirubin (Direct) in serum. For IN VITRO diagnostic use. Bilirubin is a product of hemoglobin breakdown by the reticuloendothelial system and exists in two forms. Unconjugated (indirect) bilirubin is transported to the liver bound by albumin where it becomes conjugated (direct) with glucuronic acid and excreted. Elevated serum bilirubin is indicative of impairment of the liver, excessive hemolysis, or obstruction of the biliary tract. Bilirubin determination is generally based on the reaction of bilirubin with diazotized sulfanilic acid, as described by Ehrlich (1). In this method, direct (conjugated) bilirubin couples with a diazonium salt in the presence of sulfamic acid to form the colored compound, azo-bilirubin. Image /page/2/Picture/7 description: The image shows a handwritten note on a white background. The note says "prescription use" in cursive handwriting. The note is enclosed in a rectangular box. (Division Sign-Off) Division of Clinical Laboratory Devices (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 510(k) Number Concurrence of CDRH, Office of Device Evaluation (ODE)