# K963654: Quikstrip Onestep Marijuana (THC) Test

- Pathway: 510(k) (Traditional)
- Applicant: Syntron Bioresearch, Inc.
- Decided: Feb 28, 1997 after 169 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K994410: Instant-View Marijuana (THC) Urine Dip Strip Test (2000), 0 descendants of its own
- K994405: Instant-View Marijuana Urine Cassette Test (2000), 0 descendants of its own

## Indications for use
This device is intended for medical/forensic screening of urine.

Source page: https://510kreport.com/device/K963654
Methodology: https://510kreport.com/methodology