FDA Product Code DJG: Enzyme Immunoassay, Opiates
Accurate detection of opioid use is essential in clinical toxicology, emergency medicine, and workplace drug testing. FDA product code DJG covers enzyme immunoassay systems for the detection of opiates in biological specimens.
These tests use antibody-based technology to identify the presence of opioids — including morphine, codeine, and related compounds — in urine or other samples. They are widely used as initial screening tools before confirmatory testing.
DJG devices are Class II medical devices, regulated under 21 CFR 862.3650 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Lin-Zhi International, Inc., Immunalysis Corporation and Microgenics Corporation.
FDA 510(k) Cleared Enzyme Immunoassay, Opiates Devices (Product Code DJG)
About Product Code DJG - Regulatory Context
510(k) Submission Activity
215 total 510(k) submissions under product code DJG since 1984, with 215 receiving FDA clearance (average review time: 132 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
FDA review times for DJG submissions have been consistent, averaging 120 days recently vs 132 days historically.
DJG devices are reviewed by the Toxicology panel. Browse all Toxicology devices →