(334 days)
The UBI MAGIWEL™ Marijuana metabolites is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Marijuana metabolites in human urine. (for Professional use only)
solid phase enzyme-linked immunosorbent assay(ELISA)
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.
Instead, the letter primarily focuses on the FDA's determination of substantial equivalence for the "UBI MAGIWEL Marijuana Metabolites" device, its regulatory class, and the general controls and regulations it is subject to. It also outlines responsibilities of the manufacturer regarding CLIA categorization, labeling, promotion, and advertising.
Therefore, I cannot extract the requested information from the provided input.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).