(147 days)
Qualitative visual test for the presence of Methadone and its metabolites in urine samples.
Visualine II (Also Known As SunLine) Methadone
I am sorry, but the provided text from the FDA 510(k) letter for the Visualine II (SunLine) Methadone device does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
This document is a marketing clearance letter, which states that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to a legally marketed predicate device for the stated indications for use. It outlines regulatory classifications, general controls, and contact information for further inquiries.
To answer your request, I would need to analyze a different type of document, such as the actual 510(k) summary, a clinical study report, or a validation report, which would typically contain details about performance studies and 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).