(120 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 Enteroccus 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 µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This application is for MIC determination of Ofloxacin in the range of 0.002 - 32 µg/ml with Streptococcus spp. Previously cleared applications include non-fastidious Gram positive and Gram negative aerobic bacteria, H. influenzae and S. pneumoniae.
Not Found
This document is an FDA 510(k) clearance letter for the Etest® Ofloxacin device, which is used for determining antimicrobial susceptibility. It does not contain the detailed acceptance criteria and study data requested in your prompt.
The letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to legally marketed predicate devices. It states the indications for use (for in vitro diagnostic use, determining Minimum Inhibitory Concentration (MIC) of Ofloxacin against Streptococcus spp., in the range of 0.002 - 32 µg/ml) and references previously cleared applications for other bacteria.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory clearance, not a study report.
§ 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).