(67 days)
The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Opiate metabolites in human urine. (for Professional use only)
The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA).
This document is a 510(k) clearance letter from the FDA for a medical device (UBI MAGIWEL™ Opiates Metabolites). It confirms that the device is substantially equivalent to a legally marketed predicate device. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, expert qualifications, etc.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."
This means the FDA reviewed data provided by the manufacturer (United Biotech, Inc.) to make the substantial equivalence determination, but the details of those studies are not present in this regulatory letter. To obtain that information, you would typically need to refer to the original 510(k) submission document itself, which is often not publicly available in full detail.
Therefore, I cannot provide the requested information based solely on the provided text.
§ 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).