# K093879: Mission Saliva Alcohol Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Aug 6, 2010 after 231 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
Longest line of descent: 1 generation back to K894001 (1990). 1 ancestor in all.
2 later devices descend from it; 2 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)
- K894001: Saliva Alcohol Test, Enzymatics C/O Burditt,Bowles,Radzius & Ruberry (1990) Summary page 2.

## Most influential descendants
- K121247: Alco-Screen (2013), 0 descendants of its own
- K111206: Teco Diagnostics Saliva Alcohol Test (2011), 0 descendants of its own

## Indications for use
The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentration at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used in the diagnosis of alcohol intoxication. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K093879
Methodology: https://510kreport.com/methodology