(67 days)
The UBI MAGIWEL™ Cocaine metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides miked innifullosorbent of Cocaine metabolites in human urine. (for Professional use only)
solid phase enzyme-linked immunosorbent assay(ELISA)
The provided document is a 510(k) clearance letter from the FDA for a device called "UBI MAGIWEL™ Cocaine Metabolites." This type of letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, but it does not typically contain the detailed study data, acceptance criteria, or performance metrics that would describe how the device meets specific performance standards.
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... You may, therefore, market the device, subject to the general controls provisions of the Act." This means the FDA found the device to be comparable to an existing device, which implies it's expected to perform similarly, but the performance data used to demonstrate this substantial equivalence is usually part of the 510(k) submission itself, not the clearance letter.
Therefore, I cannot extract the requested information from the provided text. The document is an approval letter, not a detailed study report.
To answer your questions, one would need to review the original 510(k) submission (K973156) made by United Biotech, Inc. to the FDA, which would contain the performance data and study details.
§ 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).