Cleared Traditional

VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup

K252867 · Advin Biotech, Inc. · Toxicology
Oct 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K252867 is an FDA 510(k) clearance for the VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Advin Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on October 9, 2025, 30 days after receiving the submission on September 9, 2025. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K252867 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2025
Decision Date October 09, 2025
Days to Decision 30 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NFT — Test, Amphetamine, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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