ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring a staff with a single snake winding around it, topped with a three-pronged design. ## Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 bioMérieux c/o Asa Karlsson Regulatory Affairs Manager 5 rue des Aqueducs Craponne, France 69290 16 2011 MAY ## Re: K102535 Trade/Device Name: Etest® Telavancin for Antimicrobial Susceptibility Testing Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test (AST) Powder Regulatory Class: Class II Product Code: JWY Dated: April 13, 2011 Received: April 19, 2011 Dear Ms. Karlsson: 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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket {1}------------------------------------------------ Page 2 - Asa Karlsson 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. fayazadym Sally A. Hojvat, M.Sc., 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 K 102538 510(k) Number (if known): Device Name: Etest® Telavancin - Antimicrobial Susceptibility: Test - MC at 0.002-32 µg/mL and 0.016-256 ug/mL. Indications For Use: This submission is for Etest® Telavancin for MIC determinations across 0.002-32 µg/mL and 0.016-256 µg/mL with Staphylooous aureus (including methicillin-resistant isolates), Entervoous faecalis (vancomycin-susceptible isolates only), Streptocous agalactive and Streptorous anginous group. Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterbaturias, Staphylovaus and Entervoors species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorouxu and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation. 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) Sae atter **Division Sign-Off** Office of In Vitro Diag Device Evaluation and S 510(k) K 102535