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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 2 0 2006 Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 982 Keynote Circle, Suite 6 Brooklyn Heights, OH 44145 k053243 Re: Trade/Device Name: Susceptibility Test Panel for Gemifloxacin 0.002-4μg/ml Gram Negative Susceptibility Test Panel for Gemifloxacin 0.002-16ug/ml Gram Positive Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LRG, JWY Dated: November 18, 2005 Received: December 5, 2005 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html Sincerely yours, Sale, a For Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K053243 ## Device Name: Susceptibility Test Panel for Gemifloxacin 0.002-4ug/ml for Gram Negative Susceptibility Test Panel for Gemifloxacin 0.002-16ug/ml for Gram Positive 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 positive and gram neqative orqanisms. This 510(k) is for the addition of Gemifloxacin in the dilution range of 0.002 - 16 ug/ml for testing gram positive and 0.002 - 4 ug/ml for testing gram negative isolates to the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance of Gemifloxacin is for: Klebsiella pneumonia. Gemifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of (0.25ug/mL) or less against most (≥90%) of the following microorganisms: however, the safety and effectiveness of gemifloxacin in treating clinical infections due to these microorganisms has not been established in adequate and wellcontrolled clinical trials. Staphylococcus aureus (Methicillin-susceptible strains only) Streptococcus pyogenes Acinetobacter Iwoffi Klebsiella oxytoca Proteus vulgaris. Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) {3}------------------------------------------------ ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 2 KaNu B. Watch for syn (Division S Division o " " cal " 510(k) Number 053243