# K233417: AllTest Fentanyl Urine Test Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AllTest Biotech Co., Ltd.
- Decided: Oct 26, 2023 after 16 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: 7 generations back to K001178 (2000). 8 ancestors in all.
9 later devices descend from it; 8 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231698: AllTest Fentanyl Rapid Test (Urine), Hangzhou AllTest Biotech Co., Ltd. (2023) Summary page 4.

## Most influential descendants
- K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (2024), 1 descendant of its own
- K243064: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test (2024), 0 descendants of its own
- K242802: CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (2024), 0 descendants of its own
- K241741: SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel (2024), 0 descendants of its own
- K240949: Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K233417
Methodology: https://510kreport.com/methodology