(138 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 application is for MIC determination of Benzylpenicillin in the range of 0.016 - 256 ug/ml or 0.002 - 32 ug/ml with streptococci other than S. pneumoniae.
Previously cleared applications include non-fastidious Gram positive aerobic bacteria, S. pneumoniae and anaerobic bacteria.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Etest® Benzylpenicillin device. It does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory responsibilities. While it mentions "Indications For Use" (page 2), which indirectly relates to what the device is intended to do, it doesn't provide the quantitative performance metrics or study details you're requesting.
Therefore, I cannot extract the information required to populate the table or answer the specific questions about the study from the provided document. The document confirms the device's clearance for marketing, but not the underlying study details.
§ 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).