(82 days)
For in vitro diagnostic use:
System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.
This 510(k) application is for System U3/Cefuroxime susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8-16 µg/ml and Resistant ≥ 32 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.
System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria. The system comprises an antibiotic gradient with MIC break-point concentrations.
This document is an FDA 510(k) clearance letter for the "System U3™ for Cefuroxime." It doesn't contain the specific details of acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more detailed section of the 510(k) submission itself.
The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs as well as, or is as safe and effective as, existing devices on the market for the same intended use. The provided text is the result of the FDA's review, not the detailed review itself.
Therefore, I cannot directly answer your questions with the provided text because the detailed information about acceptance criteria and the study that proves the device meets those criteria is not present in this regulatory clearance letter.
To provide the information you requested, I would need access to the full 510(k) submission, which would include the performance data, acceptance criteria, study design, and statistical analysis.
§ 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).