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An in vitro diagnostic test for the qualitative and semi-quantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The ONLINE DAT II Methadone assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/ml.

The provided text is a 510(k) summary for the Roche Diagnostics ONLINE DAT II Methadone II device. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a dedicated study proving the device meets specific performance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance), or ground truth establishment.

The document states: "According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence." This indicates its purpose is to demonstrate equivalence, not to present a detailed performance study against pre-defined acceptance criteria.

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