(16 days)
AllTest Fentanyl Urine Test Cassette is is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
AllTest Fentanyl Urine Test Cassette is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Urine Test Cassette consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
Here's a breakdown of the acceptance criteria and study details for the AllTest Fentanyl Urine Test Cassette, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on the lay user study demonstrating accurate detection of fentanyl at various concentrations relative to the 1 ng/mL cutoff. The reported device performance is indicated by the percentage of correct results from the lay user study, demonstrating high accuracy across different spiked concentrations.
| Acceptance Criteria (Implicit) | Reported Device Performance (Lay User Study) |
|---|---|
| Ability to correctly identify negative samples at various concentrations below cutoff (e.g., -100%, -75%, -50%, -25% of cutoff) | 100% correct for -100%, -75%, -50% cutoff samples; 95% correct for -25% cutoff samples. |
| Ability to correctly identify positive samples at various concentrations above cutoff (e.g., +25%, +50%, +75% of cutoff) | 100% correct for +25%, +50%, +75% cutoff samples. |
| Ease of understanding package insert instructions by lay users. | All lay users indicated instructions were easily followed. Flesch-Kincaid score |
§ 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).