(40 days)
Not Found.
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16 ug/ml
This document is a 510(k) clearance letter from the FDA for a medical device called the "Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin". It is a regulatory approval document and does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, it does not provide the technical details of the studies conducted to establish this equivalence, such as:
- Acceptance criteria: The specific performance thresholds the device needed to meet.
- Reported device performance: The actual results from the studies.
- Sample sizes, data provenance, expert details, adjudication methods, multi-reader multi-case study results, standalone performance, or ground truth details.
To find this information, you would typically need to refer to the 510(k) submission summary or Device Description document, which would have been submitted to the FDA by Thermo Fisher Scientific. These documents are usually publicly available through the FDA's 510(k) Premarket Notification Database, but the clearance letter itself does not contain these details.
§ 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).