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

FDA 510(k) K252867 · Advin Biotech, Inc.

Substantially Equivalent

510(k) numberK252867

Submission

Device name
VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
Applicant
Advin Biotech, Inc.
San Diego, CA, US
Received
September 9, 2025
Decision date
October 9, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NFT – Test, Amphetamine, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3100
Specialty
Clinical Toxicology

Other 510(k)s with product code NFT

510(k)DeviceApplicantDecision
K261409BioTeke® Multi-Drug Urine Test CupNFT · Traditional Bioteke Corporation (Wuxi) Co., Ltd.09/10/2026SE
K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupNFT · Traditional Assure Tech., LLC07/17/2026SE
K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelNFT · Traditional Vivachek Biotech (Hangzhou) Co., Ltd.05/22/2026SE
K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT · Traditional Guangzhou Wondfo Biotech Co., Ltd.04/28/2026SE
K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupNFT · Traditional WEBEST Biotech,, LLC03/09/2026SE
K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional Guangzhou Wondfo Biotech Co., Ltd.11/18/2025SE
K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupNFT · Traditional Vivachek Biotech (Hangzhou) Co., Ltd.09/12/2025SE
K252118CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupNFT · Traditional Hangzhou Clongene Biotech Co., Ltd.08/27/2025SE
K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional Assure Tech., LLC08/15/2025SE
K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional Hangzhou AllTest Biotech Co., Ltd.04/04/2025SE

More from Hangzhou AllTest Biotech Co., Ltd.

510(k)DeviceDecision
K201494ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardDJG · Traditional 09/17/2020SE
K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardDJG · Traditional 03/29/2019SE
K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupDKZ · Traditional 06/17/2013SE

Questions and answers

When was VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup cleared by the FDA?

VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup (K252867) received a 510(k) decision of Substantially Equivalent on October 9, 2025, 30 days after the submission was received.

What is the product code of K252867?

The FDA product code is NFT – Test, Amphetamine, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3100.