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The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. Panels are incubated for 16 - 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is to evaluate the performance for the reformulated antimicrobial agent Amoxicillin/K. Clavulanate on the MicroScan® Dried Gram-Negative MIC/Combo Panels while being read on a MicroScan® AutoScan-4 Instrument utilizing the current DMS or LabPro 1.1 Software platforms.

The Gram-Negative organisms which may be used for Amoxicillin/K. Clavulanate susceptibility testing in this panel are:

Enterobacter species
Escherichia coli
Klebsiella species
Proteus mirabilis

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding a change to a currently marketed device, specifically the performance evaluation for a reformulated antimicrobial agent (Amoxicillin/K. Clavulanate) on MicroScan® Dried Gram-Negative MIC/Combo Panels.

It describes the FDA's decision to clear the device, but it does not contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in the manufacturer's submission or a separate study report.

Therefore, I cannot provide the requested information from the text you provided. The document focuses on the regulatory outcome rather than the specifics of the underlying performance study.

To answer your request, I would need access to the actual 510(k) submission document (e.g., the "traditional 510(k)" or "special 510(k)" submission) prepared by Dade MicroScan Inc. This submission would contain the detailed study protocols, results, and analysis.

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