(72 days)
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 510(k) notification is for the addition of Cefpodoxime to Pasco panels at concentrations of 0.03 to 16 mcg/ml for determining the susceptibility of bacterial pathogens with the exception of Haemophilus and S. Pneumoniae.
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This document is a 510(k) clearance letter from the FDA for the PASCO MIC and MIC/ID Panels, specifically for the inclusion of the antimicrobial agent CEFPODOXIME. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, specific study designs, or performance data beyond the device's intended use and the regulatory approval status. Therefore, I cannot extract the requested details.
To answer your questions, I would need access to the actual 510(k) summary or the full submission document, which would typically contain the study details about how the device met its performance goals.
§ 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).