(83 days)
The Microdiagnostics, Inc. Micro-Strip for Opiate Metabolites is intended to qualitatively detect the metabolites of Opiate and Opiate-like drugs in urine.
Not Found
The provided document is an FDA 510(k) clearance letter for the "Micro-Strip for Opiate Metabolites" device. It does not contain information about acceptance criteria, device performance studies, or the specifics of such studies. Therefore, I cannot generate the requested table and answer the questions based on the given text.
The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It outlines regulatory classifications, contact information for further inquiries, and general responsibilities under the Federal Food, Drug, and Cosmetic Act.
§ 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).