(71 days)
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.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).