| K-number | K250609 |
| Device name | Sober Self-Test |
| Applicant | Sober Ip, LLC |
| Product code | DIC |
| Device class | Class II |
| Decision date | Sep 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 862.3040 |
The Sober Self-Test is a qualitative screening test that detects ethyl alcohol in human saliva to identify blood alcohol concentrations (BAC) of 0.02% or greater. It consists of a disposable test strip that develops a distinct blue color when exposed to saliva containing alcohol and is intended for in-vitro diagnostic use to diagnose alcohol intoxication.
Both the Sober Self-Test and predicate device (Alco-Screen 02) employ a qualitative method using the enzyme alcohol oxidase in a chromogenic reaction to detect alcohol in saliva, resulting in a color change for result interpretation. Both are single-use, over-the-counter test strips designed for one-time use.
Not stated in this summary.
The device is substantially equivalent because it uses the same fundamental technology (enzyme alcohol oxidase detection method) as the predicate Alco-Screen 02, with similar indications for use and comparable design. Performance testing confirmed that design differences do not introduce new safety or effectiveness concerns, and both tests provide qualitative alcohol detection in saliva through visual color interpretation.
View the full FDA submission: accessdata.fda.gov