# K111206: Teco Diagnostics Saliva Alcohol Test

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Oct 4, 2011 after 158 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 2.

## Indications for use
The Teco Saliva Alcohol Test is a screening test for the semi-quantitative detection of the presence of ethyl alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentrations (BAC) at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used for the diagnosis of alcohol intoxication. The test is intended for both prescription and over-the-counter in vitro diagnostic use. The assay is a disposable test for one-time use.

Source page: https://510kreport.com/device/K111206
Methodology: https://510kreport.com/methodology