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This submission is for Etest Voriconazole for MIC determinations across 0.002-32 µg/mL with C. albicans, C. glabrata, C. parapsilosis and C. tropicalis.

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.

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.

The provided text is a K082534 FDA 510(k) clearance letter for an antifungal susceptibility test. It focuses on the regulatory approval and indications for use. The document does not describe the specific acceptance criteria, a study proving the device meets those criteria, or any details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established.

Therefore, I cannot fulfill your request for that information based on the provided text. The document is a regulatory approval letter, not a detailed study report.

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