(170 days)
The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are in vitro screening test devices for the rapid detection of Oxycodone in human urine. The tests are standardized to detect Oxycodone at a cut-off concentration of 100 ng/mL. The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are used to obtain visual, qualitative results. The assays provide only preliminary results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. The devices are intended for professional in vitro diagnostic use only. They are not intended for over-the-counter sale to lay users.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a drug screen test. It does not contain the detailed information required to answer the questions about acceptance criteria and the specific study that proves the device meets them. This type of document typically confirms substantial equivalence to a predicate device but does not include the full technical details of performance studies.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone performance study was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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).