# K250609: Sober Self-Test

- Pathway: 510(k) (Traditional)
- Applicant: Sober Ip, LLC
- Decided: Sep 15, 2025 after 199 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)
- K121256: Alco-Screen 02, Chematics, Inc. (2012) Summary page 5.

## Indications for use
SOBER SELF-TEST is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use.

Source page: https://510kreport.com/device/K250609
Methodology: https://510kreport.com/methodology