(23 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 Trimethoprim/Sulphamethoxazole (1/19) in the range of 0.002 - 32 µg/ml with S. pneumoniae.
Previously cleared applications for Trimethoprim/Sulphamethoxazole (1/19) are nonfastidious Gram negative and Gram positive aerobic bacteria and H. influenzae.
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 the Etest® for Trimethoprim/Sulphamethoxazole. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) summary.
Therefore, I cannot provide the requested information. The letter primarily focuses on the regulatory clearance and does not delve into the specifics of the underlying validation 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).