# K191924: SAFECARE® THC Urine Strip Test

- Pathway: 510(k) (Traditional)
- Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
- Decided: Aug 16, 2019 after 29 days
- Product code: NFW (Test, Cannabinoid, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K050186 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153646: SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana, Safecare Biotech (Hangzhou) Co., Ltd. (2016) Summary page 4.

## Indications for use
SAFECARE® THC Urine Strip Test is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 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.

Source page: https://510kreport.com/device/K191924
Methodology: https://510kreport.com/methodology