# K002447: Modification to Rapid Drug Screen 9-Panel

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Nov 16, 2000 after 99 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.
3 later devices descend from it; 3 cite 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022388: Startox Drug of Abuse Screening Test (4) (2003), 0 descendants of its own
- K021114: 'Rapidtec' 5A Multiple Dip Test (2002), 0 descendants of its own
- K021006: Startox Drug of Abuse Screening Test (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K002447
Methodology: https://510kreport.com/methodology