ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. FEB - 4 19 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Edward J. Doyle General Manager & Corporate Secretary SFRI, Inc. 2082 Michelson Drive, Suite 100 Irvine, California 92612-1212 Re : K973938 R175930 Alpha 4 LS Automated Microtiterplate Processor and Reader Requlatory Class: I Product Code: JJQ Dated: December 29, 1997 Received: January 6, 1998 Dear Mr. Doyle: 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 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 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 regulation may result in regulatory 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 requlations. {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 Bitman 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}------------------------------------------------ K973938/A002/ Page of 510(k) Number (if known): 67393938 MICRO TITER PLATE ARTOMATED ﮯ ﮐﮯ ALPHA 4 AND READER Device Name:_ PROCESSOR GENERAL Indications For Use: THE ALPHA 4 LS INTENDED THE PATITER PLATE PROCESSOR AND THE ALPHA 4 LS IS TO MICROTITER PLATE AUTOMATES MICH. REACTION PRODUCTS IN THAT MEASURES IS . THE LIGHT ABORBANCE OR LUMINESCENCE READER EITHER MODE (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number k973938 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF FEREED NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Prescription Coll.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)