# K964900: Rapid Drug Screen

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Apr 14, 1997 after 138 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K984525: Rapid Drug Screen 5-Panel with Methamphetamine Test (1999), 2 descendants of its own
- K993961: Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and Opiates (3 Panel Test for Cto) (2000), 0 descendants of its own
- K993796: Rapid Drug Screen 5-Panel Drug Screening Test for Cocaine, Marijuana, Opiates, Amphetamine and Methamphetamine (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K964900
Methodology: https://510kreport.com/methodology