(77 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 Grepafloxacin in the range of 0.002 - 32 ug/ml with non-fastidious Gram negative and Gram positive aerobic bacteria, S. pneumoniae, H. influenzae and N. gonorrhoeae.
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 document is a 510(k) clearance letter for the Etest Grepafloxacin device, which determines the Minimum Inhibitory Concentration (MIC) of grepafloxacin against various bacteria. It does not contain specific details about acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on the regulatory approval of 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).