UBI MAGIWEL OPIATE METABOLITES

{0}------------------------------------------------ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. 1. 1. 1. 1. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Wuan T. Lu Director United Biotech, Inc. 110 Pioneer Way #C Mountain View, California 94041-1517 ## OCT 28 1997 Re : K973155 UBI MAGIWEL™ Opiates Metabolites Requlatory Class: II DJG Product Code: Dated: August 19, 1997 Received: August 22, 1997 Dear Wuan T. Lu: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marke is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in the 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ 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 requlatory In addition, FDA may publish further announcements action. 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 (CHIA-60), this device may requiries if it does, you should contact Cacegorization: "Io ass Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as Inib recei will assock) premarket notification. The FDA descriped in your tial equivalence of your device to a legally marketed predicate device results in a classification for your markets promos, 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 the regulation chercroad, "ALER 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 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 {2}------------------------------------------------ ## VIII 510(K)Number(if Known): Device Name: Opiate metabolites Indications for Use: The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Opiate metabolites in human urine. (for Professional use only) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number. K973155 \$\mathscr{g}\$