NFT · Class II · 21 CFR 862.3100

FDA Product Code NFT: Test, Amphetamine, Over The Counter

Point-of-care amphetamine testing enables rapid results in non-laboratory settings. FDA product code NFT covers over-the-counter amphetamine tests for consumer or near-patient use.

These lateral flow immunoassay devices provide a rapid, visual result for the presence of amphetamines in urine without laboratory equipment, enabling rapid screening in occupational health, emergency, and community settings.

NFT devices are Class II medical devices, regulated under 21 CFR 862.3100 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Guangzhou Wondfo Biotech Co., Ltd., Vivachek Biotech (Hangzhou) Co., Ltd. and Hangzhou AllTest Biotech Co., Ltd..

30
Total
30
Cleared
60d
Avg days
2017
Since
Growing category - 14 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 46d recently vs 72d historically

FDA 510(k) Cleared Test, Amphetamine, Over The Counter Devices (Product Code NFT)

30 devices
1–24 of 30
Cleared May 22, 2026
BioSieve Multi-Drug Urine Test Panel
K261280
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 35d
Cleared Apr 28, 2026
SAFElife T-Dip Multi-Drug Urine Test Panel
K260065
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 109d
Cleared Mar 09, 2026
Webest Multi-Drug Urine Cup
K260355
WEBEST Biotech,, LLC
Toxicology · 34d
Cleared Nov 18, 2025
SAFElife T-Cup Multi-Drug Urine Test Cup
K252550
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 97d
Cleared Oct 09, 2025
VINScreen Urine Drug Test Cup
K252867
Advin Biotech, Inc.
Toxicology · 30d
Cleared Sep 12, 2025
Wisdiag Multi-Drug Urine Test Cup
K252554
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 30d
Cleared Aug 27, 2025
CLUNGENE Multi-Drug Test Easy Cup
K252118
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 51d
Cleared Aug 15, 2025
AssureTech Quick Cup Tests
K252259
Assure Tech., LLC
Toxicology · 25d
Cleared Apr 04, 2025
AllTest Multi-Drug Rapid Urine Test Cup
K250727
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 24d
Cleared Feb 27, 2025
AllTest Multi-Drug Rapid Test Cup
K244043
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 59d
Cleared Feb 07, 2025
AssureTech Panel Dip Tests
K243996
Assure Tech., LLC
Toxicology · 43d
Cleared Oct 01, 2024
Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
K242498
Aicheck Biotech, Inc.
Toxicology · 40d
Cleared Sep 27, 2024
AllTest Multi-Drug Urine Test Panel
K242540
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 32d
Cleared Aug 14, 2024
PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
K242077
Aicheck Biotech, Inc.
Toxicology · 29d
Cleared Jun 17, 2024
AllTest Multi-Drug Urine Test Cup
K241428
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 28d
Cleared Nov 02, 2023
BioSieveTM Multi-Drug Urine Test Panel
K233062
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 37d
Cleared Nov 10, 2022
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
K222667
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 65d
Cleared Aug 30, 2022
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
K221871
Healstone Biotech, Inc.
Toxicology · 63d
Cleared May 05, 2022
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
K220685
Qingdao Hightop Biotech Co., Ltd.
Toxicology · 58d
Cleared Mar 24, 2021
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
K202453
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 209d
Cleared Sep 25, 2020
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
K202567
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared May 27, 2020
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K201120
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 30d
Cleared Aug 07, 2019
Accurate Multi Panel Drug Urine Test Cup
K191841
Healstone Biotech, Inc.
Toxicology · 29d
Cleared Dec 03, 2018
Wondfo T-Cup Multi-Drug Urine Test Cup
K182701
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 67d

About Product Code NFT - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code NFT since 2017, with 30 receiving FDA clearance (average review time: 60 days).

Submission volume has increased in recent years - 14 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NFT Product Code

Recent submissions under NFT have taken an average of 46 days to reach a decision - down from 72 days historically, suggesting improved FDA processing for this classification.

NFT devices are reviewed by the Toxicology panel. Browse all Toxicology devices →