(45 days)
This submission is for the addition of Tigeycline to the Etest® product range for MIC delemination across a concentration range of 0.016-256 ug/mL. In vitro susceptibility testing of Tigecycline is indicated for Gram positive and Gram negative aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and S. pneumoniae and anaerobic bacteria.
Etest® is a quantitative technique for the determination of antimicrobial susceptibility of microorganisms as tested on agar using overnight incubation. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of antimicrobial agents against microorganisms. Etest® can be used to test non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and fastidious bacteria, such as S. pneumoniae, Haemophilus Species, N. gonorrhoeae, and anaerobes.
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Here's an analysis of the provided text to extract information about the Etest® Antimicrobial Susceptibility Test – Tigecycline, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific quantitative acceptance criteria or the reported device performance in a clear, tabulated format. It is a 510(k) clearance letter, which confirms substantial equivalence to a predicate device rather than presenting detailed study results and acceptance criteria directly.
Typically, such studies would compare the Etest® results to a reference method (e.g., broth microdilution) and report metrics like Categorical Agreement (CA), Essential Agreement (EA), statistical correlation (e.g., R-squared), or percentages of minor, major, and very major errors. These quantitative measures would be compared against predefined acceptance criteria (e.g., CA ≥ 90%, Major Error
§ 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).