# K894001: Saliva Alcohol Test

- Pathway: 510(k) (Traditional)
- Applicant: Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
- Decided: Apr 5, 1990 after 304 days
- Product code: DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)
- Device class: 2
- Regulation: 21 CFR 862.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K093879: Mission Saliva Alcohol Test Strip (2010), 2 descendants of its own
- K121256: Alco-Screen 02 (2012), 1 descendant of its own
- K250609: Sober Self-Test (2025), 0 descendants of its own
- K121247: Alco-Screen (2013), 0 descendants of its own
- K111206: Teco Diagnostics Saliva Alcohol Test (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K894001
Methodology: https://510kreport.com/methodology