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This submission is for Etest Doripenem for MIC determinations across 0.002-32 µg/mL with Gram negative aerobic bacteria such as Enterchacteriaceae, Accretobacer baumanii, Pseudomonas aeraginesa and Gram negative anaerobic bacteria such as Bacteroides aacae, B. fragilis, B.thetaiotaorracron, B. uniformis and B. ulgatus. Etest is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria such as Enterchaceriane, Pseudomnas, Staphylococus and Enteroxous species and fastidious bacteria, such as anaerobes, N. gonombeae, S. preumoniae, Streptoxous and Haemophilus species. The system comprises a predelined 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.

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This submission is for the addition of Tigeycline to the Etest® product range for MIC delemination across a concentration range of 0.016-256 ug/mL. In vitro susceptibility testing of Tigecycline is indicated for Gram positive and Gram negative aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and S. pneumoniae and anaerobic bacteria. Etest® is a quantitative technique for the determination of antimicrobial susceptibility of microorganisms as tested on agar using overnight incubation. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of antimicrobial agents against microorganisms. Etest® can be used to test non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and fastidious bacteria, such as S. pneumoniae, Haemophilus Species, N. gonorrhoeae, and anaerobes.

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For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation. (Original FDA clearance for Etest - file K913459/A) This Etest 510(k) submission is for an additional antibiotic i.c. Etest for MIC deemination of This Etest 310(K) Submission is 10.016 - 256 µg/ml with E. faecalis and E. Jaeium (vancomycin-Daptomyen in the MIC faires of over including methicillin resistant strains), coagulase negative Staphylococcus spp. and ß-haemolytic Streptococcus spp.

Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation.

For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaxeae, Pseudomonas, Staphylooocus and Enteroous species and fastidious bacteria, such as anaerobes, Pneumooocus, Streptocous, Gonocous and Haemophilus species. The system comprises a predefined antibiotic gradient that is used to determine the minimum inhibitory concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This 510(k) submission is for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae.

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Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions. This 510k submission is for an application for in wire diagnostic use of Etest for MIC determination of fluconazole, itraconazole and flucytosine with Candida species.

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For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus, Streptococcus, Gonococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Cefditoren in the range of 0.002 - 32 µg/ml with S. pneumoniae (penicillin susceptible strains only) and H. influenzae.

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For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both aerobic bacteria, such as Enterobacteriaceae, non-fastidious Gram negative and Enterococcus species and fastidious bacteria, such as Pseudomonas, Staphylococcus and Enterococcus and Haemophilus species. The system comprises a preformed antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Ertapenem in the range of 0.002-32 μg/mL against Enterobacteriaceae, E. coli, K. pneumoniae, S. aureus (methicillin susceptible strains), S. pneumoniae (penicillin susceptible strains), S. agalactiae, S. pyogenes, H. influenzae (β-lactamase negative strains), Bacteroides spp, Prevotella bivia, P. asaccharolytica and Peptostreptococcus spp.

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