# K992949: Screeners Marijuana Test, Drugscreen Dip Marijuana Test

- Pathway: 510(k) (Traditional)
- Applicant: Drug Detection Devices, Ltd.
- Decided: Dec 27, 1999 after 117 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Drug Detection Devices Marijuana Test is a rapid, qualitative, competitive binding immunoassay for the determination of Cannabinoids and its metabolites in urine. The tesi provides only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. This test is not intended to be used in monitoring cannabinoid levels.

Source page: https://510kreport.com/device/K992949
Methodology: https://510kreport.com/methodology