(67 days)
THE UBI MAGIWEL™ Amphetamine metabolites is a solid phase enzyme-linked immonosorbent assay(ELISA). This test provides a specific and sensitive assay to qualitatively detect the major amphetamine metabolites in human urine.
solid phase enzyme-linked immonosorbent assay(ELISA)
The provided text does not contain information on the acceptance criteria and study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the UBI MAGIWEL™ Amphetamine Metabolites device, indicating that it has been deemed substantially equivalent to a predicate device. It defines the device and its intended use but does not detail the performance study or specific acceptance criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, or adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Information on a standalone performance study.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).