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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white. Public Health Service SEP 1 1 2006 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145 k062022 Re: Trade/Device Name: Sensititre® Haemophilus inflenzae/Streptococcus pneumoniae (HP) MIC susceptibility plates Azithromycin (0.25-2 ug/ml), Amoxicillin/clavulanic acid 2:1 ratio (2/1-16/8 µg/ml), Cefotaxime (0.12-4 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG Dated: July 12, 2006 Received: July 17, 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, Watson 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 062022 Device Name: Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Azithromycin (0.25-2μg/ml), Amoxicillin/clavulanic acid 2:1 ratio (2/1-16/8 µg/ml), Cefotaxime (0.12-4 µg/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 species to azithromycin (0.25 - 2 ug/mL), amoxicillin/clavulanic acid (2/1 -- 16/8 ug/mL), cefotaxime (0.12 - 4 ug/mL) for use with the Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates . The approved primary "indications for use" and clinical significance of azithromycin is for: Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes ## With activity against: Streptococci (Groups C, F, G) Viridans group streptococci. The approved primary "indications for use" and clinical significance of amoxicillin/clavulanic acid 2:1 ratio is for: Streptococcus pneumoniae ** ## The following in vitro data are available but their clinical significance is unknown: Streptococcus pyogenes ** - **These are non beta lactamase producing organisms, and therefore are susceptible to amoxicillin alone. The approved primary "indications for use" and clinical significance of cefotaxime is for: Streptococcus pneumoniae Streptococcus pyogenes Streptococcus spp. Fred Lee W. Poole sion Sign-Or Office of In Vitro Diagnostic Device Evaluation and Safe 510(k) K06 2022 pg. 1 of 2 {3}------------------------------------------------ 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) Luddie W. Cool. ision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Satety 510(k) K062027 Pg. 2 of 2