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The provided text is an FDA 510(k) clearance letter for an in vitro diagnostic device, specifically the "MTS Imipenem-relebactam 0.002/4-32/4 ug/mL" for antimicrobial susceptibility testing. This document does not contain the detailed study information required to answer your request.
FDA 510(k) clearance letters generally confirm that a device is substantially equivalent to a predicate device and outline regulatory compliance. They do not typically include the full clinical study reports, acceptance criteria, or performance data in the level of detail you are asking for.
To find the information you've requested, you would typically need to consult:
- The 510(k) summary document: This voluntary document, often available on the FDA's 510(k) database, provides a summary of the clinical and/or performance data and acceptance criteria.
- The full 510(k) submission: This is a much more extensive document submitted to the FDA, which includes all the detailed study protocols, results, and analyses. These are generally not publicly available in their entirety.
- Manufacturer's product insert/labeling: This might contain some performance data.
Therefore, based solely on the provided text, I cannot complete your request. The letter confirms the device (MTS Imipenem-relebactam) is cleared for marketing but does not provide the specific study details.
§ 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).