# K994410: Instant-View Marijuana (THC) Urine Dip Strip Test

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Jun 21, 2000 after 176 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
Longest line of descent: 1 generation back to K963654 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963654: Quikstrip Onestep Marijuana (THC) Test, Syntron Bioresearch, Inc. (1997) Summary page 1.

## Indications for use
Instant-View Marijuana (THC) Urine Dip StripTest is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9, THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only. The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminarily positive results are used.

Source page: https://510kreport.com/device/K994410
Methodology: https://510kreport.com/methodology