Cleared Traditional

Sober Self-Test

K250609 · Sober Ip, LLC · Toxicology

Sep 2025

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K250609 is an FDA 510(k) clearance for the Sober Self-Test, a Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (Class II — Special Controls, product code DIC), submitted by Sober Ip, LLC (Southfield, US). The FDA issued a Cleared decision on September 15, 2025, 199 days after receiving the submission on February 28, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number	K250609 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2025
Decision Date	September 15, 2025
Days to Decision	199 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	DIC — Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3040