MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT - 92001 Ms. Cindy Knapp Trek Diagnostic Systems 29299 Clemens Rd. Suite 1-K Westlake Ohio 44145 Re: k991810/S1 Trade/Device Name: Sensititre® YestOne™ MIC Susceptibility Plate Regulation Number: 866,1640 Regulation Name: Susceptibility Test Panel Regulatory Class: Class II Product Code: NGZ Dated: October 11, 2000 Received: September 19, 2001 Dear Ms. Knapp: . We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 Section 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 21 CFR Part 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 Part 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 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}------------------------------------------------ 1991810 510(k) Number (if known): Device Name: Susceptibility Test Panel Indications For Use: The Sensititre® YeastOne™ MIC Susceptibility plate is an in vitro diagnostic product for determining the clinical susceptibility of Candida species. This 510(k) is for this MIC only panel, the antifungal agents at concentrations listed as follows: | <b>Antifungal Agent</b> | <b>Dilution Range</b> | |-------------------------|-----------------------| | Fluconazole | 0.125 - 256 | | 5-Flucytosine | 0.03 - 64 | | Itraconazole | 0.008 - 16 | Organisms with indications for testing include non-fastidious yeast isolates of Candida species. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Steven Butman (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K991810 Prescription Use OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________