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The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the addition of: "Cefoxitin Screen". The "Cefoxitin Screen ( 6ug/ml) " can be used to predict the presence of mecAmediated resistance in Staphylococcus aureus. Isolates for which cefoxitin MIC tests > 6 (positive growth) should be reported as oxacillin resistant. Those which have cefoxitin MIC's of

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The provided document is a 510(k) clearance letter from the FDA for a device called "Sensititre® 18-24 hour MIC or BP Susceptibility Test System" with a Cefoxitin Screen (6μg/ml) for Staphylococcus aureus. This document grants market clearance for the device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the manufacturer's 510(k) submission or a separate clinical study report.

Therefore, I cannot provide the requested information. The clearance letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

To obtain the requested information, you would need to consult the actual 510(k) submission (K073558) itself, which would contain:

• Details of the performance studies conducted.
• The specific acceptance criteria used for the Cefoxitin Screen's ability to predict mecA-mediated resistance in Staphylococcus aureus.
• The reported device performance against those criteria.
• Information on sample size, ground truth establishment, expert qualifications, etc.

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