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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 Ceftriaxone in the range of 0.016 - 256 ug/ml or 0.002 - 32 ug/ml for H. influenzae, N. gonorrhoeae and Streptococcus spp.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the Etest® Ceftriaxone. It confirms that the device is substantially equivalent to legally marketed predicate devices and allows the manufacturer to market it.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot extract the requested information from the given input.

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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 µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This application is for MIC determination of Ceftriaxone in the range of 0.016 - 256 µg/ml or 0.002 - 32 ug/ml for Streptococcus spp.

Previously cleared applications include H. influenzae and S. pneumoniae.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Etest® Ceftriaxone device. It declares the device substantially equivalent to legally marketed predicate devices.

However, the letter does not contain any information regarding specific acceptance criteria, study performance, sample sizes, expert qualifications, adjudication methods, or other detailed performance study information.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed submission document for the device.

Ask a specific question about this device