SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES 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 lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. 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 Cleveland, OH 44131 NOV - 1 2006 Re: k062816 Trade/Device Name: Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Meropenem (0.25-2 ug/ml). Moxifloxacin (0.25 - 8 µg/ml), Penicillin (0.03 - 8 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: JWY, LRG Dated: September 15, 2006 Received: September 20, 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) I his icher will anow you to ough mating of substantial equivalence of your device to a legally premarket notification: "The PDIs 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, If you desire specific introllion and advertising of your device, please contact the Office of In of questions on the prometic Device Evaluation and Safety at (240)276-0450. Also, please note the vitro Daglesue Deliver by reference to premarket notification" (21CFR Part 807.97). It guilation entition on your responsibilities under the Act may be obtained from the Other general mionmation on Jour respectional 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, autry 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): \$(0) 2816 Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Meropenem (0.25-2ug/ml), Moxifloxacin (0.25-8 µg/ml), Penicillin (0.03-8 µg/ml) Indications For Use: The Sensitire® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus influenzae; Streptococcus pneumoniae and Streptococcus species. This 510(k) is for the addition of Streptococcus spps to Meropenem (0.25 -2 ug/mL), Moxifloxacin (0.25-8 ug/mL), Penicillin (0.03-8 ug/mL) for use with the Sensititle® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates . The approved primary "indications for use" and clinical significance of Meropenem is for: Streptococcus pneumoniae (penicillin-susceptible isolates only) Streptococcus agalactiae Streptococcus pyogenes Viridans group streptococci The approved primary "indications for use" and clinical significance of Moxifloxacin is for Streptococcus pneumoniae, (including penicillin-resistant strains) Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown; Streptococcus agalactiae Viridans group streptococci The approved primary "indications for use" and clinical significance of Penicillin is for: Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci Streptococcus agalactiae Streptococcus (beta-hemolytic group ) Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) CDRH, Office of In Vitro Diagnostic Devices (OIVD) Freddie L. Poole Division Sign-Off n Viro Diagnostic Devic 1628 033 0 8 6 2222 510(k) K062816