QUANTA LITE B2 GPI IGA

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 20 1997 Mr. Brys Myers Requlatory Affairs INOVA Diagnostics, Inc. 10451 Roselle Street San Diego, California 92121 Re : K973006 QUANTA Lite™ B2 GPI IgA ELISA Trade Name: Regulatory Class: II Product Code: MSV Dated: Auqust 11, 1997 Received: August 13, 1997 Dear Mr. Myers: 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 You provisions of the Federal Food, Druq, and Cosmetic Act (Act). 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 requirement, 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 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours, Steven Autman 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 of 510(k) Number (if known): k 97 300 k QUANTA Lite™ B,GPI IgA Device Name: ## Indications For Use: semiquantitative enzyme linked immunoassay for detecting IgA A class autoantibody to f2 glycoprotein I (B2 GPI) for use as an aid diagnosis of certain autoimmune disease thrombotic in the disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like disorders. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Teta E. Mason (Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number Image /page/2/Picture/8 description: The image shows the words "Prescription Use" with an underline and a check mark above the underline. Below that, the text "(Pcx 21 CFR 801.109)" is shown. The text is in bold font. The image appears to be a label or a part of a document. OR ## Over-The-Counter Use (Optional Format 1-2-96)