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To detect Escherichia coli, Klebsiella oxytoca, and K. pneumoniae strains suspected of harboring suspected extended spectrum betalactamase enzymcs.

MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime (0.015-64 ug/ml)

The provided text is a 510(k) premarket notification approval letter for the MicroScan® Dried Gram Negative MIC/Combo Panels Cefpodoxime. This document is a regulatory approval and does not contain the detailed study results, acceptance criteria, or ground truth establishment methods that would typically be found in a study report or the 510(k) submission itself.

Therefore, I cannot provide the requested information from the text given. The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates that the FDA reviewed the manufacturer's submission which would have contained the study information, but this specific letter is only the approval notification.

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