(88 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms. This 510(k) is for the addition of Daptomycin in the dilution range of 0.03 -64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance of Daptomycin is for: Staphylococcus aureus (including methicillin-resistant strains),Enterococcus faecalis (vancomycin-susceptible strains only), Streptococcus agalactiae and Steptococcus pyogenes. In vitro data, without clinical correlation is provided for: Staphylococcus epidermidis (including methicillin-resistant strains) Enterococcus faecalis ( vancomycin-resistant strains), Enterococcus faecium (including vancomycin-resistant strains)and Staphylococcus haemolyticus.
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The provided text is a 510(k) premarket notification letter for a medical device (Susceptibility Test Panel for Daptomycin), not a report of a study proving a device meets acceptance criteria. Therefore, I cannot extract the specific information requested in your prompt as it is not present in the document.
The document states that the FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This indicates a regulatory approval process based on comparison to existing devices, rather than a detailed study report with specific acceptance criteria and performance metrics as you've requested.
To provide the information you're looking for (acceptance criteria, study details, sample sizes, ground truth establishment, etc.), you would typically need a clinical study report or a premarket submission that includes such data.
§ 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).