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
49–72 of 150
Cleared Dec 21, 1999
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE
K993796
American Bio Medica Corp.
Toxicology · 42d
Cleared Aug 05, 1999
MICRO-STRIP FOR MARIJUANA METABOLITES
K991516
Microdiagnostics, Inc.
Toxicology · 97d
Cleared Jul 07, 1999
RAPIDONE - MARIJUANA TEST
K990818
American Bio Medica Corp.
Toxicology · 118d
Cleared Apr 27, 1999
REDI-TEST THC
K990870
Redwood Biotech, Inc.
Toxicology · 42d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Nov 18, 1998
DBEST TETRAHYDROCANNABINOL TEST KIT
K983188
Ameritek, Inc.
Toxicology · 68d
Cleared Jul 22, 1998
UBI MAGIWEL MARIJUANA METABOLITES
K973154
United Biotech, Inc.
Toxicology · 334d
Cleared Jun 29, 1998
GENIE CUP INTEGRATED SCREENING DEVICE
K980836
Applied Technology Ventures, LLC
Toxicology · 117d
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 Feb 13, 1998
STC CANNABINOIDS MICRO-PLATE EIA
K973750
OraSure Technologies, Inc.
Toxicology · 135d
Cleared Sep 25, 1997
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122
Phamatech
Toxicology · 36d
Cleared Jul 03, 1997
ONE STEP MARIJUANA CARD TEST
K970548
Teco Diagnostics
Toxicology · 141d
Cleared Jun 25, 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
K971841
Bionike Laboratories, Inc.
Toxicology · 37d
Cleared Apr 28, 1997
IMMULITE CANNABINOIDS
K963916
Diagnostic Products Corp.
Toxicology · 210d
Cleared Feb 28, 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654
Syntron Bioresearch, Inc.
Toxicology · 169d
Cleared Feb 20, 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207
Drial Consultants, Inc.
Toxicology · 189d
Cleared Oct 30, 1996
VERDICT THC
K963516
Editek, Inc.
Toxicology · 57d
Cleared Oct 30, 1996
VISUALINE COMBO V (COCAINE/THC) TEST
K963606
Sun Biomedical Laboratories, Inc.
Chemistry · 51d
Cleared Aug 20, 1996
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
K951853
Tcpi, Inc.
Toxicology · 487d
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 May 02, 1995
VISUALINE II CANNABINOIDS (THC)
K950445
Sun Biomedical Laboratories, Inc.
Toxicology · 95d
Cleared Apr 05, 1995
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 78d