AUTODIMER ASSAY MODEL # 1431

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Patrick J. O'Leary, Ph.D. Vice President/General Manager Xtrana, Inc. 6025 Nicolle Street Ventura, California 93003 MAR 1 5 2002 k012755 Re: Trade/Device Name: AutoDimer Assay Regulation Number: 21 CFR § 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Products Assay Regulatory Class: II Product Code: DAP Dated: February 8, 2002 Received: February 11, 2002 Dear Dr. O'Leary: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller is substantially equivalent (for the indications ferenced above and nave acteringedly marketed predicate devices marketed in interstate for use stated in the encrosule) to regarry interest and the Medical Device American of to commence provision to May 20, 1978, the oncordance with the provisions of the Federal Food, Drug, devices that have occh recuired in asses approval of a premarket approval application (PMA). and Cosmetic Act (Act) market the device, subject to the general controls provisions of the Act. The You may, therefore, market are act include requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) this existing major regulations affecting your device can may be subject to such additional controls. Existing major regulation FDA may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of I outers stogening your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I DA s issuation of a backed complies with other requirements of the Act that FDA has made a determination that your device complies with other require that TDA has Inade a decommancin and Joinistered by other Federal agencies. You must of any I edital statutes and regulations and and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 807), adomig (21 OFR Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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_1_of_1_ 510(k) Number (if known): K012755 Device Name: AutoDimer Assay_ Indications For Use: AutoDimer Assay is an immunoturbidimetric assay used for the AutoDimer Assay 15 an Intalion of the fibrin degradation product Qualitreactic develminma, using the Hitachi 911, Hitachi 902, D-dimer In numan prasma) abing one in anstruments. AutoDimer Assay utilizes antibody-coated latex particles. The Autobiller Assur dorities are coated with a monoclonal antibody reacting with fibrin D-dimer or fragment D of fibrinogen but not with with Fibringen, allowing D-dimer determination in human plasma. Laboratory measurements of D-dimer have been shown to be of significance in the assessment of pulmonary embolism, deep significans and disseminated intravascular coagulation. (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number Koi7755 (Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)