(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 Enterocccus 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 Benzylpenicillin in the range of 0.016 - 256 µg/ml or 0.002 - 32 µg/ml with non-fastidious Gram positive aerobic bacteria, S. pneumoniae, streptococci other than S. pneumoniae, N. gonorrhoeae and anaerobic bacteria.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the Etest® Benzylpenicillin device. It acknowledges that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria and study information typically found in a device submission.
Specifically, the document does not provide any of the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on regulatory approval based on substantial equivalence to existing predicate devices. It states the indications for use and classification information. To obtain the requested study details, one would typically need access to the full 510(k) submission, which is not included here.
§ 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).