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 and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus symbol. 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 OCT 26 2006 Re: k062783 Trade/Device Name: Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates, for Gemifloxacin (0.03-0.5 ug/ml), Linezolid (1 - 8 ug/ml), Levefloxacin (0.5 - 16 ug/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 14, 2006 Received: September 18, 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 requirernents, 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 guestions 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 antonm 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): 62793 Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Gemifloxacin (0.03-0.5ug/ml), Linezolid (1-8 ug/ml), Levofloxacin (0.5-16 ug/ml) ## Indications For Use: The Sensititre® 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 Gemifloxacin (0.03 -0.5 ug/mL), Linezolid (0.5-4 ug/mL), Levolloxacin (0.5-16 ug/mL) for use with the Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The approved primary "indications for use" and clinical significance of Gemilloxacin is for: Streptococcus pneumoniae The following in vitro data are available but their clinical significance is unknown: Streptococcus pyogenes The approved primary "indications for use" and clinical significance of Linezolid is for Streptococcus pneumoniae, (including multi-drug resistant strains) Streptococcus agalactiae Streptococcus pvogenes The following in vitro data are available but their clinical significance is unknown: Viridans group streptococci The approved primary "indications for use" and clinical significance of Levofloxacin is for: Streptococcus pneumoniae (including multi-drug resistant strains) Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown: Viridans group streptococci Streptococcus agalactiae Streptococcus (Group C/F) Streptococcus (Group G) Streptococcus milleri 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) | | Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | | | | | | | |--|-------------------------------------------------------------------|--|--|--|--|--|--| |--|-------------------------------------------------------------------|--|--|--|--|--|--| Freddie M. Focke Division Sign-Off ;vice Evaluation and Safe K062783