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Abuscreen ONLINE BENZ 200 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Abuscreen ONLINE BENZ 200 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The matrix is urine and the levels of Benzodiazepines (ng/mL) are 0, 100, 200, 400.

The provided text states that "No clinical or nonclinical tests were necessary to establish substantial equivalence." Therefore, there is no information in the document to fill in the requested table and answer the study-related questions.

Without a study being conducted or detailed in the provided text, it is not possible to describe acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a 510(k) summary for Abuscreen ONLINE® BENZ 200 Calibrators, stating its substantial equivalence to a predicate device based on similar technological characteristics rather than new performance data.

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