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 Syva Co., Lin-Zhi International, Inc. and Diagnostic Products Corp..
215
Total
215
Cleared
132d
Avg days
1984
Since
Declining activity -
6 submissions in the last 2 years
vs 16 in the prior period
Consistent review times:
115d avg (recent)
FDA 510(k) Cleared Enzyme Immunoassay, Opiates Devices (Product Code DJG)
215 devices
Cleared
Jan 29, 2026
Labcorp Fentanyl Urine Visual Test
Medtox Diagnostics, Inc.
Toxicology
157d
Cleared
Jan 23, 2026
Evidence MultiSTAT DOA Urine MultiPlex
Randox Laboratories Limited
Toxicology
318d
Cleared
Jan 16, 2026
LZI Buprenorphine II Enzyme Immunoassay
Lin-Zhi International, Inc.
Toxicology
115d
Cleared
Sep 11, 2025
SEFRIA™ Hydrocodone Oral Fluid
Immunalysis Corporation
Toxicology
31d
Cleared
Aug 15, 2025
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative
Healgen Scientific, LLC
Toxicology
50d
Cleared
Jun 18, 2025
LZI Fentanyl III Enzyme Immunoassay
Lin-Zhi International, Inc.
Toxicology
20d
Cleared
Jun 14, 2024
BioSieve™ Fentanyl FIA Test Kit
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology
150d
Cleared
May 10, 2024
Dochek® Multi-Drug Urine Test Dipcard Rx
Guangzhou Decheng Biotechnology Co., Ltd.
Toxicology
57d
Cleared
Mar 08, 2024
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
Co-Innovation Biotech Co., Ltd.
Toxicology
254d
Cleared
Feb 23, 2024
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
Shanghai Accurature Diagnostics Co., Ltd.
Toxicology
211d
Cleared
Jan 09, 2024
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
Hangzhou Laihe Biotech Co., Ltd.
Toxicology
134d
Cleared
Dec 20, 2023
Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
Chemtron Biotech, Inc.
Toxicology
104d
Cleared
Dec 13, 2023
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
Guangzhou Decheng Biotechnology Co., Ltd.
Toxicology
104d
Cleared
Nov 09, 2023
ARK Hydrocodone Assay
ARK Diagnostics, Inc.
Chemistry
147d
Cleared
Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
Randox Laboratories Limited
Chemistry
595d
Cleared
Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex
Randox Laboratories Limited
Toxicology
492d
Cleared
Sep 27, 2023
CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation
Chemistry
173d
Cleared
Jul 31, 2023
AllTest Fentanyl Rapid Test (Urine)
Hangzhou AllTest Biotech Co., Ltd.
Toxicology
49d
Cleared
Jul 25, 2023
Emit® II Plus Buprenorphine Assay
Siemens Healthcare Diagnostics, Inc.
Toxicology
418d
Cleared
Mar 31, 2023
BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology
60d
Cleared
Feb 06, 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Xenta Biomedical Science Co., Ltd.
Toxicology
132d
Cleared
Dec 13, 2022
Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
Shenzhen Superbio Technology Co., Ltd.
Toxicology
342d
Cleared
May 09, 2022
Immunalysis Tapentadol Urine HEIA
Lmmunalysis Corporation
Toxicology
523d
Cleared
Dec 22, 2021
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
Immunalysis Corporation
Toxicology
380d
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 - 6 submissions in the last 24 months compared to 16 in the prior period.
FDA 510(k) Review Time - DJG Product Code
FDA review times for DJG submissions have been consistent, averaging 115 days recently vs 132 days historically.
DJG devices are reviewed by the Toxicology panel. Browse all Toxicology devices →