# K970395: Quikstrip One Step Methamphetamine

- Pathway: 510(k) (Traditional)
- Applicant: Drial Consultants, Inc.
- Decided: Jun 26, 1997 after 143 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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
- K994406: Instant-View Methamphetamine Urine Dip Strip Test (2000), 0 descendants of its own
- K994400: Instant-View Methamphetamine Urine Cassette Test (2000), 0 descendants of its own

## Indications for use
INTENDED USE Syntron’s QuikStrip One Step Methamphetamine assay 1s a rapid, qualitative, competitive binding immunoassay for the determination of

Source page: https://510kreport.com/device/K970395
Methodology: https://510kreport.com/methodology