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This submission is for Etest® Moxifloxacin for MIC determinations across 0.002-32 µg/mL with B. fragilis, B. thetaiotaomirron, C. perfringens and Peptostreptoroccus spp.

Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobaterianas, Staphylocourus and Entervacus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, Streptowers 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.

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This is an FDA 510(k) clearance letter for a medical device (Etest® Moxifloxacin for Antimicrobial Susceptibility Testing, K093604), not a study report. Therefore, the provided text does not contain the acceptance criteria or study details that typically accompany a device performance study.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: This document states the device is "substantially equivalent" to predicate devices, but it does not specify any quantitative performance metrics or acceptance criteria that were used to establish this equivalence. It's a regulatory clearance, not a scientific publication of a study's results.
• Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set details: These are all aspects of a detailed study design and results. The 510(k) letter only confirms the device's clearance for marketing.

To get the information requested, one would typically need to consult a separate document, often referred to in the 510(k) summary as a "clinical study report" or "performance data." This letter itself does not provide those details.

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