(68 days)
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.
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).