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The Detectabuse® Liquid control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

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This is a 510(k) premarket notification for a medical device called "Detectabuse® Liquid Control." This document focuses on the regulatory approval of this device, rather than a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, the requested information regarding specific acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study is not present in the provided document.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device meeting the same "indications for use" as existing devices, rather than providing specific performance metrics against pre-defined acceptance criteria in a clinical study context.

In the context of this 510(k) summary, the "acceptance criteria" are broad regulatory requirements for substantial equivalence, and the "study" referred to would be the comparison to predicate devices, which is not detailed in terms of performance metrics.

In summary, the provided document does not contain the specific performance data and study details requested in your prompt.

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