(146 days)
Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions. This 510k submission is for an application for in wire diagnostic use of Etest for MIC determination of fluconazole, itraconazole and flucytosine with Candida species.
Not Found
The provided document is an FDA 510(k) clearance letter for an antimicrobial susceptibility test. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive submission document.
Therefore, I cannot extract the information required in the prompt (acceptance criteria, reported device performance, sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from this letter.
The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use. It doesn't present the underlying data or the specific criteria against which that data was evaluated.
§ 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).