SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

{0}------------------------------------------------ 2098 Gaither Road Rockville MD 20850 Food and Drug Administration Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures facing to the right, with their heads overlapping. ## AUG 21 1998 Ms. Eileen McCafferty Requlatory Affairs Manager Shield Diagnostics Limited The Technoloqy Park Dundee, DD2 1SW United Kingdom Re: ка80885/51 Shield ACTIVATED FACTOR X11 ELISA Assay Trade Name: Requlatory Class: II Product Code: GGP Dated: May 26, 1998 Received: May 29, 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 leqally marketed predicate 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 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 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 requlation (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 requlation 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.qov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman 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__ I ___of l 510(k) Number (if known): _ K 980885 ACTIVATED FACTOR X11 (FX11a) ELISA TEST _ Device Name: Indications for Use: The Shield Activated Factor XI I (FXIIa) assay is a semi-quantitative direct enzyme immunoassay for the detection, in human citrated plasma, of activated factor X11 (x-X1 la and B- X11a). The test may be used as an index of activation of the contact (intrinsic) system of coagulation Rodia (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_k 98 0 88 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use .......... (Per 21 CFR 801. 109) OR Over-The -Counter Use ........................................................................................................................................................ Optional Format 1-2-96)