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 Jul 25, 2012
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
K121557
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared Jun 23, 2011
LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
K110239
Lin-Zhi International, Inc.
Chemistry · 148d
Cleared May 20, 2011
CANNABINOIDS URINE TEST
K110182
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 119d
Cleared Apr 08, 2011
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
K092269
Randox Laboratories, Ltd.
Toxicology · 619d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
K101744
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
K063164
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
K050936
ACON Laboratories, Inc.
Toxicology · 71d
Cleared Jun 08, 2005
ON CALL MULTI-DRUG HOME TEST CUP
K050878
ACON Laboratories, Inc.
Chemistry · 63d
Cleared Mar 11, 2005
ON CALL MULTI-DRUG HOME TEST
K050050
ACON Laboratories, Inc.
Toxicology · 60d
Cleared Nov 23, 2004
RANDOX CANNABINOIDS ASSSAY
K041142
Randox Laboratories, Ltd.
Toxicology · 207d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213
Roche Diagnostics Corp.
Toxicology · 80d
Cleared Aug 15, 2002
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887
Lin-Zhi International, Inc.
Toxicology · 69d
Cleared Jun 10, 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
K014066
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared May 23, 2002
LIFESIGN DOA 4 (THC/OPI/COC/MET)
K014193
Princeton BioMeditech Corp.
Toxicology · 153d
Cleared Mar 13, 2002
CANNABINOIDS
K013247
Abbott Laboratories
Toxicology · 166d
Cleared Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557
ACON Laboratories, Inc.
Toxicology · 118d
Cleared Jun 21, 2000
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
K994410
Alfa Scientific Designs, Inc.
Toxicology · 176d
Cleared Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
K994164
Roche Diagnostics Corp.
Toxicology · 126d

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.