FDA Product Code LDJ: Enzyme Immunoassay, Cannabinoids
Cannabis use is widespread and its detection is required in workplace and forensic settings. FDA product code LDJ covers enzyme immunoassay systems for cannabinoid detection in biological specimens.
These tests detect THC metabolites — particularly 11-nor-9-carboxy-THC — in urine, enabling screening for cannabis use in workplace drug testing, probation monitoring, and clinical settings. Cannabis metabolites can be detected for days to weeks after use.
LDJ devices are Class II medical devices, regulated under 21 CFR 862.3870 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Lin-Zhi International, Inc., Immunalysis Corporation and Healgen Scientific, LLC.
FDA 510(k) Cleared Enzyme Immunoassay, Cannabinoids Devices (Product Code LDJ)
About Product Code LDJ - Regulatory Context
510(k) Submission Activity
150 total 510(k) submissions under product code LDJ since 1981, with 150 receiving FDA clearance (average review time: 112 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
LDJ devices are reviewed by the Toxicology panel. Browse all Toxicology devices →