LDJ · Class II · 21 CFR 862.3870

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
1–24 of 150
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
K232732
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)
K232604
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 135d
Cleared Mar 17, 2023
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
K223162
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
K192515
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 28d
Cleared Jun 05, 2015
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
K151203
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
K141320
Lin-Zhi International, Inc.
Toxicology · 373d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213
Roche Diagnostics Corp.
Toxicology · 80d
Cleared Mar 13, 2002
CANNABINOIDS
K013247
Abbott Laboratories
Toxicology · 166d
Cleared Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164
Roche Diagnostics Corp.
Toxicology · 126d
Cleared Apr 06, 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461
Dade Behring, Inc.
Toxicology · 55d
Cleared Jan 18, 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984
Syva Co.
Toxicology · 55d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
K981584
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Apr 28, 1997
IMMULITE CANNABINOIDS
K963916
Diagnostic Products Corp.
Toxicology · 210d
Cleared Apr 03, 1996
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677
Beckman Instruments, Inc.
Toxicology · 110d
Cleared Mar 06, 1996
FRONTLINE CANNABIS
K954497
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Apr 05, 1995
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 78d
Cleared Feb 22, 1995
EMIT IIC CANNABINOID ASSAY
K940158
Syva Co.
Toxicology · 406d
Cleared Dec 29, 1994
CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS
K944086
Beckman Instruments, Inc.
Toxicology · 177d
Cleared Nov 21, 1994
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS
K944088
Beckman Instruments, Inc.
Toxicology · 139d
Cleared Oct 01, 1993
EMIT(R) THC 50/100 NG ASSAY
K932716
Syva Co.
Toxicology · 119d
Cleared Feb 27, 1992
IL TEST CANNABINOID, 35282
K920418
Instrumentation Laboratory CO
Toxicology · 27d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
K912757
Roche Diagnostic Systems, Inc.
Toxicology · 35d

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.