# K121247: Alco-Screen

- Pathway: 510(k) (Traditional)
- Applicant: Chematics, Inc.
- Decided: Mar 22, 2013 after 331 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: 2 generations back to K894001 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093879: Mission Saliva Alcohol Test Strip, ACON Laboratories, Inc. (2010) Summary page 1.

## Indications for use
ALCO-SCREEN® is a semi-quantitative screening test used to estimate the Blood Alcohol Concentration (BAC) using human saliva. The test strip estimates BAC at the 0.00%, 0.02%, 0.04%, 0.08% and 0.3% levels. Results are used in the diagnosis of alcohol use or intoxication. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K121247
Methodology: https://510kreport.com/methodology