# K971218: Quikstrip One Step Amphetamine Test

- Pathway: 510(k) (Traditional)
- Applicant: Drial Consultants, Inc.
- Decided: May 30, 1997 after 58 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 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
- K994395: Instant-View Amphetamine Urine Cassette Test (2000), 17 descendants of its own
- K063545: Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette, Dip-Strip), Cocaine, Methamphetamine (2007), 16 descendants of its own
- K152122: Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) (2016), 13 descendants of its own
- K173303: INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (2018), 12 descendants of its own
- K182738: Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) (2019), 9 descendants of its own

## Indications for use
Syntron’s QuikStrip One Step Amphetamine assay is a rapid, qualitative, com@etitive binding immunoassay for the determination of Amphetamine in urine. The test provides only preliminary data which should be confirmed by other methods such as gas chromatograp]i;ylmass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated®. Syntron’s QuikStrip One Step Amphetamine Test is not inténded to monitor drug levels, but only to screen urines for the presen¢e of amphetamine and its metabolites.

Source page: https://510kreport.com/device/K971218
Methodology: https://510kreport.com/methodology