(85 days)
For in vitro diagnostic use:
Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.
This Etest 510(k) application is for MIC determination of Trovafloxacin in the range of 0.002 - 32 µg/ml with.non-fastidious Gram negative and Gram positive aerobic bacteria, S. pneumoniae, H. influenzae and anaerobic bacteria.
Not Found
I am sorry, but based on the provided text, the document is a letter from the FDA to AB Biodisk regarding the clearance of their device, Etest® Trovafloxacin, and an "Indications For Use" statement. It does not contain information on the acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot fulfill your request to describe these elements.
§ 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).