(71 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 µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.
This Etest 510(k) application is for MIC determination of Cefotaxime in the range of 0.016 - 256 µg/ml or 0.002 - 32 µg/ml with non-fastidious Gram positive and Gram negative aerobic bacteria, H. influenzae, Streptococcus spp., N. gonorrhoeae and anaerobic bacteria.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Etest® Cefotaxime". It does not contain the detailed study results, acceptance criteria, or performance metrics requested in the prompt.
The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the company's submission of a 510(k) notification, which would have included data to support the substantial equivalence claim. However, these specific study details are not present in this regulatory letter itself.
Therefore, I cannot extract the information requested in your prompt from the provided text. To answer your questions, I would need the actual 510(k) submission document or a separate clinical study report for the Etest® Cefotaxime.
§ 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).