# K240654: SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
- Decided: Apr 10, 2024 after 34 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
SAFECARE Fentanyl Urine Test Cassette is a 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. The test is intended for over-the-counter use and for in vitro diagnostic use only. SAFECARE FYL Urine Test Cassette is a 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.

Source page: https://510kreport.com/device/K240654
Methodology: https://510kreport.com/methodology