SHIELD HELICO-G2 ELISA KIT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAR 17 1998 Eileen McCafferty Regulatory Affairs Manager Shield Diagnostics Limited The Technology Park Dundee, DD2 1SW. U.K. Re: K972981 Trade Name: Shield Helico G2 Elisa Kit Regulatory Class: I Product Code: LYR Dated: December 22, 1997 Received: January 5, 1998 Dear Ms. McCafferty: 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 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 Regulations. 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 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. {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 Sutman 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 __ 1 _ of _____ 1 ______ 1 ______________________________________________________________________________________________________________________________________________ 510(k) Number (if known): _K972981 Device Name: _Shield Helico G2 Elisa kit______________________________________________________________________________________________________________________________________ Indications for Use: The Shield Helico G2 kit is a qualitative indirect enzyme immunoassay for the detection of the IgG class of antibodies for Helicobacter pylori (H pylori) in human serum or plasma (EDTA or Heparin ). The test is intended as an aid in the diagnosis of H pylori infection in adults and is not definitive in isolation. Antibodies represent one parameter in a multi-criteria diagnostic process. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Labo 510(k) Number Prescription Use (Per 21 CFR 801. 109) : OR Over-The -Counter Use_________________________________________________________________________________________________________________________________________________________ Optional Format 1-2-96)