# K234006: AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test

- Pathway: 510(k) (Traditional)
- Applicant: Allsource Screening Solutions
- Decided: Mar 21, 2024 after 93 days
- Product code: NGL (Test, Opiates, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001178 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233417: AllTest Fentanyl Urine Test Cassette, Hangzhou AllTest Biotech Co., Ltd. (2023) Summary page 4.

## Indications for use
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 fentanyl 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. GC/MS or LC/MS 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.

Source page: https://510kreport.com/device/K234006
Methodology: https://510kreport.com/methodology