(118 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 application is for MIC determination of Ceftriaxone in the range of 0.016 - 256 µg/ml or 0.002 - 32 ug/ml for Streptococcus spp.
Previously cleared applications include H. influenzae and S. pneumoniae.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the Etest® Ceftriaxone device. It declares the device substantially equivalent to legally marketed predicate devices.
However, the letter does not contain any information regarding specific acceptance criteria, study performance, sample sizes, expert qualifications, adjudication methods, or other detailed performance study information.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed submission document for the device.
§ 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).