SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 982 Keynote Circle, Suite 6 Brooklyn Heights, Ohio 44145 AUG 3 1 2006 k062190 Re: Trade/Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Tigecycline 0.004-8 µg/ml for Streptococcus spp. Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: JWY, LRG Dated: July 26, 2006 Received: July 31, 2006 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}------------------------------------------------ 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)276-0450. 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, Sally, artton 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): K 062190 Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Tigecycline 0.004-8μg/ml for Streptococcus spp. Indications For Use: The Sensititre HP Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious organisms. This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 ug/ml for testing Streptococcus spp. isolates on the Sensititre HP susceptibility system. The approved primary "Indications for Use" and clinical significance of Tigecycline is for: Aerobic facultative Gram-postive microorganisms Streptoccus agalactiae Streptococcus pyogenes Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and . S. constellatus) Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Freddie thi. Poole Division Sign-Off **Division Sign-Off** Office of In Vitro Diagnostic Device Evaluation and Safety 100k) .