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
150 devices
73–96 of 150
Cleared Feb 22, 1995
EMIT IIC CANNABINOID ASSAY
K940158
Syva Co.
Toxicology · 406d
Cleared Feb 22, 1995
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
K945550
Princeton BioMeditech Corp.
Toxicology · 100d
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 Nov 04, 1994
CANNABINOID EIA ASSAY
K943998
Diagnostic Reagents, Inc.
Toxicology · 136d
Cleared Nov 02, 1994
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
K944562
Microgenics Corp.
Chemistry · 64d
Cleared Aug 01, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337
Microgenics Corp.
Toxicology · 77d
Cleared May 17, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT
K940649
Microgenics Corp.
Toxicology · 91d
Cleared Jan 13, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591
Microgenics Corp.
Toxicology · 55d
Cleared Oct 01, 1993
EMIT(R) THC 50/100 NG ASSAY
K932716
Syva Co.
Toxicology · 119d
Cleared May 12, 1993
BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
K931598
Biosite Incorporated
Toxicology · 41d
Cleared May 06, 1993
STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA
K930654
Solarcare Technologies Corp,Inc.
Toxicology · 86d
Cleared Jan 26, 1993
MICROPLATE CANNABINOIDS ASSAY
K924815
Solarcare Technologies Corp,Inc.
Toxicology · 123d
Cleared Feb 27, 1992
CANNABINOID EIA TEST
K920311
Diagnostic Reagents, Inc.
Toxicology · 35d
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
Cleared Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592
Roche Diagnostic Systems, Inc.
Toxicology · 129d
Cleared Apr 03, 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
K910589
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Apr 03, 1991
TARGET(TM) CANNABINOIDS-V TEST
K910892
V-Tech, Inc.
Toxicology · 30d
Cleared Apr 03, 1991
TARGET(TM) CANNABINOIDS-R TEST
K910893
V-Tech, Inc.
Toxicology · 30d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 100 NG ASSAY
K904568
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 20 NG ASSAY
K904570
Syva Co.
Toxicology · 78d
Cleared Dec 26, 1990
EMIT(R) II CANNABINOID 50 NG ASSAY
K904571
Syva Co.
Toxicology · 78d
Cleared Dec 13, 1990
ABUSCREEN ONTRAK FOR THC
K904856
Roche Diagnostic Systems, Inc.
Toxicology · 45d