FDA Product Code NGL: Test, Opiates, Over The Counter
Point-of-care opiate testing enables rapid results in emergency and clinical settings without laboratory infrastructure. FDA product code NGL covers over-the-counter opiate tests for consumer use.
These lateral flow immunoassay devices provide a rapid, visual result for the presence of opiates in urine without laboratory equipment. They are used in home monitoring, workplace screening, and community settings.
NGL devices are Class II medical devices, regulated under 21 CFR 862.3650 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Healgen Scientific, LLC, Guangzhou Decheng Biotechnology Co., Ltd. and Hangzhou AllTest Biotech Co., Ltd..
FDA 510(k) Cleared Test, Opiates, Over The Counter Devices (Product Code NGL)
About Product Code NGL - Regulatory Context
510(k) Submission Activity
23 total 510(k) submissions under product code NGL since 2008, with 23 receiving FDA clearance (average review time: 52 days).
Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 7 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NGL have taken an average of 58 days to reach a decision - up from 47 days historically. Manufacturers should account for longer review timelines in current project planning.
NGL devices are reviewed by the Toxicology panel. Browse all Toxicology devices →