(67 days)
1 Methadone Assay: The 1 methadone assay has been designed for use only on the 1 analyser for qualitative detection of methadone, a narcotic pain-relieving drug, in urine using a cutoff concentration of 300 ng/mL. Qualitative results obtained can be utilised in the diagnosis and treatment of methadone use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The 1 Methadone Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Evidence Drugs of Abuse Calibrators: The Evidence Drugs of Abuse Calibrators are liquid Calibrators containing Methadone. There are 9 levels of calibrator. They have been developed for use in calibration of the 1 system. The Evidence Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
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The provided text is a 510(k) clearance letter from the FDA for the "1 Methadone Assay and Evidence Drugs of Abuse Calibrators." This document determines substantial equivalence to a predicate device and outlines the intended use. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or its effect size.
- Standalone performance study for the algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in the 510(k) submission document itself, particularly in the sections detailing analytical and clinical performance studies, which are not part of this clearance letter.
§ 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).