(77 days)
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 Gatifloxacin in the dilution range of 0.008 - 16 µg/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates. The approved primary "Indications for Use" and clinical significance of Gatifloxacin is for: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. In vitro data, without clinical correlation is provided for: Acinetobacter lwoffi, Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus vulgaris
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a diagnostic device, specifically a "Susceptibility Test Panel." It approves the addition of Gatifloxacin to an existing panel for testing gram-negative isolates. However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.
The letter is a regulatory approval document and focuses on the "substantial equivalence" of the device to legally marketed predicate devices, not on the detailed performance study data itself.
Therefore, I cannot provide the requested information based on the given text.
§ 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).