(71 days)
Qualitative visual teit for the presence of Methliam phetamine and its metabolites in Uside sample
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Visualine® II Methamphetamine." It states that the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This letter is a regulatory approval document, not a scientific study report.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. To answer your questions, I would need access to the actual 510(k) submission documentation, which would include the study data and performance claims.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).