(93 days)
AllSource Drug Detector FenTest 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.
The AllSource Drug Detector Fentanyl Test is a rapid, one-step immunoassay for the qualitative detection of fentary] in human urine at the cutoff concentrations of 1 ng/mL.
This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GCMS is the preferred confirmatory method. Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated. It is for in vitro diagnostic use only.
AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllSource Drug Detector Fentanyl Test device consists of a Test Dip Card and a package insert. Each Test Dip Card is sealed with sachets of desiccant in an aluminum pouch.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the AllSource Drug Detector Fentanyl Test:
Device: AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
Indications for Use: Qualitative detection of Fentanyl in human urine at the cutoff concentration of 1 ng/mL. Provides preliminary test results, requiring further confirmatory methods (GC/MS or LC/MS). For in vitro diagnostic use only. For Over-The-Counter Use.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined table with numerical targets for each performance characteristic. Instead, device performance is presented and implicitly deemed acceptable by the FDA for substantial equivalence. The following table synthesizes the performance characteristics presented in the document:
| Performance Characteristic | Acceptance Criteria (Implicit from FDA Clearing) | Reported Device Performance |
|---|---|---|
| Precision | Consistent results around cutoff. | For each of 3 lots: |
| -100% to -50% cut off: 60-/0+ (100% negative) | ||
| +25% to +100% cut off: 60+/0- (100% positive) | ||
| -25% cut off: 44-46 negative, 14-16 positive | ||
| Cut off: 28-30 positive, 30-32 negative | ||
| Stability | Demonstrated stability over time. | Stable at 2-30 °C for 24 months (based on accelerated stability study). |
| Interference | No significant interference from common substances at specified concentrations. | Many compounds showed no interference at 100µg/mL or specified concentrations (e.g., Acetone, Ethanol, Albumin, Glucose, etc.). See source for extensive list. |
| Specificity (Cross-Reactivity) | Limited cross-reactivity with structurally similar compounds, and no cross-reactivity with unrelated opioids/drugs below specified concentrations. | Fentanyl (Cutoff=1ng/mL): |
- Acetyl fentanyl: 1 ng/mL (100% cross-reactivity)
- Isobutyryl fentanyl, Butyryl fentanyl: 2.5 ng/mL (40% cross-reactivity)
- Norfentanyl, 4-Fluoro-isobutyrylfentanyl: 50 ng/mL (2% cross-reactivity)
- Acrylfentanyl, Ocfentanil, Valeryl fentanyl, Para-fluorobutyrylfentanyl (p-FBF), (±)-3-cis-methylfentanyl, Acetyl norfentanyl: 10 ng/mL (10% cross-reactivity)
- Furanyl fentanyl: 7.5 ng/mL (13.3% cross-reactivity)
- (±) β-hydroxythiofentanyl: 5 ng/mL (20% cross-reactivity)
- Despropionyl fentanyl (4-ANPP): 2500 ng/mL (0.04% cross-reactivity)
- Carfentanil, Sufentanil, Remifentanil, Alfentanil: 10000 ng/mL (0.01% cross-reactivity)
- ω-1-Hydroxyfentanyl: 20000 ng/mL (0.005% cross-reactivity)
- Norcarfentanil: 100000 ng/mL (
§ 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).