(53 days)
For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both aerobic bacteria, such as Enterobacteriaceae, non-fastidious Gram negative and Enterococcus species and fastidious bacteria, such as Pseudomonas, Staphylococcus and Enterococcus and Haemophilus species. The system comprises a preformed antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Ertapenem in the range of 0.002-32 μg/mL against Enterobacteriaceae, E. coli, K. pneumoniae, S. aureus (methicillin susceptible strains), S. pneumoniae (penicillin susceptible strains), S. agalactiae, S. pyogenes, H. influenzae (β-lactamase negative strains), Bacteroides spp, Prevotella bivia, P. asaccharolytica and Peptostreptococcus spp.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Etest® Ertapenem device, an antimicrobial susceptibility test. While it indicates that the device has been found substantially equivalent to a predicate device, it does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a comprehensive submission.
Therefore, I cannot extract the requested information. The letter only broadly states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
To answer your request, I would need access to the full 510(k) submission document, which would include the study design, acceptance criteria, test results, and other details about the device's performance.
§ 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).