SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

{0}------------------------------------------------ Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized symbol representing the human profile, depicted as three overlapping silhouettes. Food and Drug Administration 2098 Gaither Road · Rockville MD 20850 ## SEP 2 5 2002 Ms. Cynthia C. Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145 Re: k022775 > Trade/Device Name: Susceptibility Test Panel Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: August 2, 2002 Received: August 9, 2002 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 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 1 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/odrh/dsmaldsmamain.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}------------------------------------------------ 510 (k) Number (If known): Device Name: Susceptibility Test Panel Indications For Use: The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. ## This 510(k) is for the climination of limitations in the sensititre technical insert. The limitation to be removed are as follows: 2.) The AutoReader system should not be used to read Enterococcus sp. Due to the lack of performance data on emerging resistant Enterococcus sp., all enterococcal strains should be read manually. A nitrocefin Beta lactamase test should be performed to detect B-lactamase producing strains of enterococci. 3.) The ability of the Sensititre System to detect resistance with amoxicillin/clavulanic acid with Enterococcus sp., and gentamicin (500 ug/mL) with Enterococcus faccium is unknown because too few resistant strains were available at the time of comparative testing. The addition of the following limitation in the Sensititre technical insert: The autoreader system should not be used Nitrofurantoin with Enterococcus species. Nitrofurantoin should be read manually. The ability to detect resistance with nitrofuantoin is unknown because too few resistant strains were available at the time of comparative testing. ## (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 Laboratory Devices | 510(k) Number | K022775 | |---------------|---------| |---------------|---------| Prescription Use W (Per 21 CFR 801.109 OR Over-The-Counter Use