(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 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 Fosfomycin in the range of 0.064 - 1024 µg/ml with non-fastidious Gram negative and Gram positive aerobic bacteria.
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.
The provided text is a 510(k) clearance letter for the Etest® Fosfomycin device and includes a brief description of its indications for use. However, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, and performance metrics as requested.
The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs similarly and is as safe and effective. To make this determination, the FDA would have reviewed studies submitted by the manufacturer, but the specifics of those studies (acceptance criteria, sample sizes, ground truth establishment, etc.) are not included in this document.
Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need to review the actual 510(k) submission (K981136) or other related study reports from Ab Biodisk.
§ 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).