# K012159: Rapid Drug Screen

- Pathway: 510(k) (Special)
- Applicant: American Bio Medica Corp.
- Decided: Jul 25, 2001 after 33 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023869: 'Rapidtec'-5M-Multiple Dip Test (2003), 1 descendant of its own
- K073078: Rapid Tox Cup (2008), 0 descendants of its own
- K022388: Startox Drug of Abuse Screening Test (4) (2003), 0 descendants of its own
- K021006: Startox Drug of Abuse Screening Test (2002), 0 descendants of its own

## Indications for use
The ABM Rapid Drug Screen™ is for the determination of Cocaine, Opiates, Marijuana, PCP, Barbiturates, Benzodiazepines, Tricyclics, Methamphetamine and Amphetamines in human urine. The test is used to obtain visual, qualitative results and is intended for professional use only.

Source page: https://510kreport.com/device/K012159
Methodology: https://510kreport.com/methodology