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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 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 Levofloxacin in the range of 0.002 - 32 µg/ml with non-fastidious Gram negative and Gram positive aerobic bacteria, S. pneumoniae and H. influenzae.

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The provided text is a 510(k) premarket notification letter from the FDA to AB Biodisk regarding their Etest for Levofloxacin. It confirms the device's substantial equivalence but does not contain the acceptance criteria, study details, or performance data that would typically be found in a detailed study report or clinical trial summary.

Therefore, I cannot extract the requested information. The document focuses on regulatory approval rather than a scientific study's methodology and results.

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