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., Hangzhou AllTest Biotech Co., Ltd. and Aicheck Biotech, Inc..
FDA 510(k) Cleared Test, Amphetamine, Over The Counter Devices (Product Code NFT)
About Product Code NFT - Regulatory Context
510(k) Submission Activity
29 total 510(k) submissions under product code NFT since 2017, with 29 receiving FDA clearance (average review time: 61 days).
Submission volume has increased in recent years - 14 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NFT have taken an average of 45 days to reach a decision - down from 75 days historically, suggesting improved FDA processing for this classification.
NFT devices are reviewed by the Toxicology panel. Browse all Toxicology devices →