(20 days)
Immunoassay for the qualitative detection of methadone in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug.
Not Found
This FDA document is a 510(k) clearance letter for the AccuSign® MTD device, an immunoassay for the qualitative detection of methadone in human urine. It does not contain information about the acceptance criteria or the study that proves the device meets them.
The letter explicitly states: "we have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements... and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions."
This indicates that the device was cleared based on its substantial equivalence to a predicate device, not through a new clinical study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding study details (sample size, expert qualifications, adjudication, MRMC study, training set details, ground truth types) is not present in this document.
§ 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).