(139 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates.
This 510(k) is for the newly approved Tedizolid in the dilution range of 0.03-4 ug/ml for testing non-fastidious gram positive organisms on the Sensititre 18 - 24 hour MIC panel.
The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates:
Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin susceptible (MSSA) isolates) Enterococcus faecalis
Not Found
The provided text is a 510(k) premarket notification approval letter for an antimicrobial susceptibility test system. It describes the device and its intended use, but it does not contain information about acceptance criteria, device performance, study details (sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details of the study that proves the device meets acceptance criteria, as this information is not present in the provided text.
The document focuses on the regulatory approval of the "Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Tedizolid" for clinical susceptibility testing of non-fastidious isolates, specifically Staphylococcus aureus and Enterococcus faecalis. It outlines the device's name, regulation number, product code, and the regulatory class (Class II). It also reiterates that the device is substantially equivalent to legally marketed predicate devices.
§ 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).