# K192301: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.
- Decided: Sep 20, 2019 after 28 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: 9 generations back to K945610 (1995). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182530: BIOEASY Multi-Drug Test Cup, Shenzhen Bioeasy Biotechnology Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K231978: BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 (2023), 0 descendants of its own

## Indications for use
BIOEASY Marijuana Test Dip Card is 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. For in vitro diagnostic use only. BIOEASY Marijuana Test Strip is 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. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K192301
Methodology: https://510kreport.com/methodology