(47 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 Rifampicin in the range of 0.002 - 32 µg/ml with S. pneumoniae: * * * * * * * *
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.
The provided document is a 510(k) clearance letter from the FDA for a device called Etest Rifampicin used for determining antimicrobial susceptibility. It does not contain specific details about acceptance criteria, a study that proves the device meets those criteria, or information on AI/ML algorithms.
The document primarily focuses on:
- Device identification: Etest® Rifampicin with indications for S. Pneumonia.
- Regulatory classification: Class II, Product Code JWY.
- Substantial equivalence determination: The FDA found the device substantially equivalent to legally marketed predicate devices.
- Indications for Use: For in vitro diagnostic use, determining Minimum Inhibitory Concentration (MIC) of Rifampicin against S. pneumoniae in the range of 0.002 - 32 µg/ml, as well as general susceptibility testing for other bacteria.
Therefore, I cannot provide the requested information based on the content of this document. It lacks the details required to answer your questions regarding acceptance criteria, study design, expert qualifications, sample sizes, or AI/MRMC studies.
§ 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).