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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/Amoxicillin/clavulanic acid susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4/2 µg/ml and Resistant ≥ 8/4 µg/ml for use with Staphylococcus, and Susceptible ≤ 8/4 µg/ml, Intermediate 16/8 µg/ml and Resistant ≥ 32/16 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 and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This document is an FDA 510(k) clearance letter for a medical device called "System U3™ for Amoxicillin/clavulanic acid," which is used for antimicrobial susceptibility testing. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not include details about specific acceptance criteria or the study used to prove the device meets those criteria. This type of information is typically found within the full 510(k) submission, not in the clearance letter itself.

Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text.

Based on the nature of the document, the following points can be inferred:

• Device Type: In vitro diagnostic device for antimicrobial susceptibility testing.
• Regulatory Classification: Class II.
• Purpose: To determine the susceptibility categories (Susceptible, Intermediate, Resistant) of microorganisms to Amoxicillin/clavulanic acid.
• Ground Truth (implied for test set): Likely based on established antimicrobial susceptibility testing methods and MIC breakpoints, which are specified in the "Indications for Use" (e.g., Susceptible ≤ 4/2 µg/ml for Staphylococcus).
• Study Type (implied): For devices like this, the FDA typically requires studies demonstrating agreement with a predicate device or established reference method across a range of bacterial isolates with known susceptibility profiles. However, the specifics of such a study (sample size, expert involvement, adjudication, etc.) are not in this document.

To answer your questions, I would need access to the full 510(k) submission or a summary of its data.

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