510(k) K252867

VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup by Advin Biotech, Inc. — Product Code NFT

K252867 is an FDA 510(k) premarket notification submitted by Advin Biotech, Inc. for the device "VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup". The FDA issued a decision of Substantially Equivalent on October 9, 2025. The device falls under product code NFT (Test, Amphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3100. Advin Biotech, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2025
Date Received
September 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Amphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type