(60 days)
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The provided text is an FDA 510(k) clearance letter for an antimicrobial susceptibility test (AST) system. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets.
- Data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC study details or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established for training and test sets.
This document merely confirms that the device, Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam, is substantially equivalent to legally marketed predicate devices. The information you are requesting would typically be found in the 510(k) submission itself, which is a much more comprehensive document than the clearance letter.
§ 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).