(90 days)
The Amedica Drug Screen Test THC/COC/OPI/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine: THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY. This test is intended for use by over-the-counter (OTC) consumers as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a drug test cup (Amedica Drug Test Cup). It outlines the device's indications for use and lists the drugs it can detect along with their respective cut-off levels. However, this document does not contain the detailed study information, acceptance criteria, or performance data that would allow for a comprehensive answer to your request.
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device likely met certain performance standards in efficacy and safety to achieve this equivalence, but the specifics of those studies and their results are not present in this document.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance: This document only lists the cutoff levels for each drug but does not specify performance metrics like sensitivity, specificity, accuracy, or acceptance criteria for these metrics.
- Sample sizes, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, type of ground truth used, training set details: None of this information is available in the provided FDA clearance letter. This type of detail would typically be found in the 510(k) submission itself or in a separate study report, not in the clearance letter.
The letter focuses on the regulatory determination of substantial equivalence and outlines the general controls and regulations applicable to the device.
In summary, the provided document does not contain the specific study details needed to answer your request about acceptance criteria and device performance.
§ 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).