(20 days)
Opiates 2000 Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in quantitative and qualitative analyses of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3". It acknowledges that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the provided text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It is a regulatory approval document, not a performance study report.
Therefore, I cannot provide the requested information based on the input text. The elements you asked for (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are typically found in a clinical study report or a technical performance document, which this is not.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.