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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 negative and gram positive organisms. This 510(k) is for the addition of Streptomycin in the concentrations of 1000ug/ml and 2000ug/ml to the Sensititre 18-24 hour MIC panel for use as a Screening Test for High-Level Aminoglycoside Resistance in Enterococcus species. The clinical and colonial significance of Streptomycin is for: Enterococcus species.

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.

The provided text is an FDA 510(k) clearance letter for the "Sensititre 18 – 24 hours Susceptibility Plates – Streptomycin 1000 µg/ml and 2000 µg/ml". This document does not contain the detailed acceptance criteria or the specific study details that prove the device meets those criteria.

The information typically requested in your prompt (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is part of a detailed study report that would be submitted to the FDA, but not typically included in the 510(k) clearance letter itself. The letter simply states that the FDA has reviewed the submission and determined that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need access to the actual 510(k) submission documentation or a separate study report detailing the performance evaluation of the Sensititre system for Streptomycin.

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