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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/Ampicillin susceptibility testing based on the MIC breakpoints of Susceptible ≤ 8 µg/ml, Intermediate 16 µg/ml and Resistant ≥ 32 µg/ml for use with non-fastidious Gram negative aerobic bacteria, Susceptible ≤ 0.25 µg/ml and Resistant ≥ 0.5 µg/ml for use with Staphylococcus, Susceptible ≤ 8 µg/ml and Resistant ≥ 16 µg/ml for use with Enterococcus.

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 and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

The provided document is a 510(k) clearance letter from the FDA for the System U3™ for Ampicillin. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

Therefore, I cannot provide the requested information based on the given input document.

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