SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS

{0}------------------------------------------------ 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 SEP 2 1 2005 Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 982 Keynote Circle, Suite 6 Cleveland, OH 44131 k052091 Re: Rosever Susceptibility Test Panel for Tigecycline 0.015-16µg/ml Gram Negative Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY, LRG, LTT Dated: July 29, 2005 Received: August 2, 2005 Dear Ms. Knapp: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalent be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroome) to togens actment date of the Medical Device Amendments, or to conninered proc to they 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices mat have been receasined trequire approval of a premarket approval application (PMA). alle Cosmetic Act (110t) that to not request to the general controls provisions of the Act. The Tourmay, therefore, market and as Act include requirements for annual registration, listing of general controls provisions of the 120 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 your device is eassified (660 across) in Existing major regulations affecting your device it may be subject to backlers Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, Occements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I DTT of losames or our device complies with other requirements of the Act that I DA has made a dotenmistered by other Federal agencies. You must of any I cacal stututes and regaratents, including, but not limited to: registration and listing (21 Compry with an the Hig (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}------------------------------------------------ ## Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) I his leter will anow you to oogin mailsoning of substantial equivalence of your device to a legally premarket notification: "The sults 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 you destro specific introlion and advertising of your device, please contact the Office of In of questions on the prometers and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may onain only generational 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/industry/support/index.html Sincerely yours, Sally, a Hogg 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 K052091 510(k) Number (if known): ## Device Name: Susceptibility Test Panel for Tigecycline 0.008-16ug/ml for Gram Positive Susceptibility Test Panel for Tigecycline 0.015-16μg/ml for Gram Negative Indications For Use: The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product dlaghostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of Tigecycline in the dilution range of 0.008 - 16 i his 510(k) is for the addition of 1.95 year. ug/ml for testing gram positive and 0.015-16μg/ml for testing gram negative ught for testing grain positive and the panel. The approved primary isolates to the Sensitite 10 - 2 Phisiance of Tigecycline is for: ## Aerobic facultative Gram-postive microorganisms Enteroccus faecalis (vancomycin-susceptible isolates only) Enteroccus facture (varioomy cillin-susceptible and -resistant isolates) Streptoccus agalactiae Streptococcus pyogenes Onoploododododopy) Gram-negative microorganisms Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae In vitro data, without clinical correlation is provided for: Aerobic and facultative Gram-postive microorganisms Aeromonas hydrophila Citrobacter koseri Enterococcus avium Enterococcus casseliflavus Enterococcus faecalis (vancomycin-resistant isolates) Enterococcus faecium (vancomycin-susceptible and -resistant isolates) Enterococcus gallinarum Cherococcus galimaram Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates) Staphylococcus haemolyticus Aerobic and facultative Gram-negative microorganisms Acinetobacter baumannii Division Sign-Off > Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K052091 {3}------------------------------------------------ Enterobacter aerogenes Serratia marcescens Stenotrophomonas maltophilia Prescription Use _ × (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) Ludolph Poole Division Sign-Off Division Sign-Off Page 2 of _ 2__ Office of In Vitro Diagnostic Device Evaluation and Safety 4052091 510(k)