(56 days)
The Monitect® MDMA Drug Screen Cassette Test and the Fastect™ II Drug Screen Dipstick Test are in vitro screen tests that contains chromatographic immunoassays for the rapid detection of 3,4-Methylenedioxymethamphetamine (MDMA) in human urine above the cutoff concentration of 500 ng/mL. Both the Monitect® and Fastect™ II devices provide visual, qualitative results only. The devices are intended for in vitro diagnostic use in professional and laboratory settings only. The devices are not intended for over-the-counter sale to lay persons.
Not Found
The provided text describes a 510(k) premarket notification for two drug screen tests, Monitect® MDMA Drug Screen Cassette Test and Fastect™ II MDMA Drug Screen Dipstick Test, designed to detect MDMA in human urine. However, the document is a regulatory approval letter and an indications for use statement; it does not contain a study that proves the device meets specific acceptance criteria.
Therefore, I cannot directly extract the requested information about acceptance criteria and a detailed study from this document. The information typically found in such a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is absent from this regulatory communication.
The document only states that the FDA reviewed the 510(k) and determined the devices are substantially equivalent to legally marketed predicate devices for the stated indications for use. This determination implies that the manufacturer would have submitted data demonstrating performance, but that specific data is not included in this letter.
§ 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).