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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 Cefdinir in the range of 0.016 - 256 µg/ml with non-fastidious Gram negative and Gram positive aerobic bacteria and H. influenzae.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) submission for a medical device (Etest® Cefdinir). This document does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

The letter confirms the device's substantial equivalence to predicate devices and outlines regulatory compliance. It does not detail specific performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies for evaluating the device's performance.

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