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 Syva Co., Roche Diagnostic Systems, Inc. and Abbott Laboratories.
150
Total
150
Cleared
112d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Enzyme Immunoassay, Cannabinoids Devices (Product Code LDJ)
150 devices
Cleared
Jan 17, 2024
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
Co-Innovation Biotech Co., Ltd.
Toxicology
132d
Cleared
Jan 10, 2024
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
Hangzhou Laihe Biotech Co., Ltd.
Toxicology
135d
Cleared
Mar 17, 2023
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
Healgen Scientific, LLC
Toxicology
161d
Cleared
Oct 11, 2019
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology
28d
Cleared
Mar 18, 2016
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
Hangzhou Clongene Biotech Co., Ltd.
Toxicology
81d
Cleared
Nov 02, 2015
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
Nantong Egens Biotech Co., Ltd.
Toxicology
48d
Cleared
Jun 05, 2015
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
Immunalysis Corporation
Toxicology
31d
Cleared
May 28, 2015
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
Lin-Zhi International, Inc.
Toxicology
373d
Cleared
Sep 25, 2014
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
Polymed Therapeutics, Inc.
Toxicology
28d
Cleared
Jun 06, 2014
HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
Healgen Scientific, LLC
Chemistry
94d
Cleared
Oct 18, 2013
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
Lumiquick Diagnostics, Inc.
Chemistry
262d
Cleared
Oct 18, 2013
RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
Biophor Diagnostics, Inc.
Toxicology
102d
Cleared
Feb 07, 2013
TOXCUP DRUG SCREEN CUP
Branan Medical Corp.
Chemistry
162d
Cleared
Dec 05, 2012
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
Omega Laboratories, Inc.
Toxicology
86d
Cleared
Jul 25, 2012
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry
61d
Cleared
May 01, 2012
PSYCHEMEDICS CANNABINOIDS EIA
Psychemedics Corp.
Toxicology
300d
Cleared
Jun 23, 2011
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
Lin-Zhi International, Inc.
Chemistry
148d
Cleared
May 20, 2011
CANNABINOIDS URINE TEST
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry
119d
Cleared
Apr 08, 2011
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
Randox Laboratories, Ltd.
Toxicology
619d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
Microgenics Corp.
Chemistry
290d
Cleared
Dec 28, 2006
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
Ortho-Clinical Diagnostics, Inc.
Toxicology
71d
Cleared
Jun 24, 2005
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
ACON Laboratories, Inc.
Toxicology
71d
Cleared
Jun 08, 2005
ON CALL MULTI-DRUG HOME TEST CUP
ACON Laboratories, Inc.
Chemistry
63d
Cleared
May 15, 2005
NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE
Nano-Ditech Co.
Toxicology
68d
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.