(120 days)
The Ameditech ImmuTest™ Drug Screen OPIATES is an In Vitro screen test for the qualitative detection of opiate metabolites in human urine at cut-off concentration of 2000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.
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The provided document is a 510(k) premarket notification letter from the FDA for a device called "Ameditech ImmuTest™ Drug Screen Opiates." This document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) letter is an approval notification based on substantial equivalence to a legally marketed predicate device, not a detailing of the device's performance studies or clinical trial results. Therefore, I cannot extract the requested information from this document.
§ 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).