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
97–120 of 150
Cleared Nov 20, 1990
LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS
K904541
Abbott Laboratories
Toxicology · 47d
Cleared Nov 01, 1990
MICROZYME THC ENZYME IMMUNOASSAY TEST KIT
K904635
Immunotech Corp.
Toxicology · 21d
Cleared May 17, 1990
MILENIA(TM) CANNABINOIDS
K901568
Diagnostic Products Corp.
Toxicology · 43d
Cleared May 14, 1990
HYCOR ACCUPINCH THC TEST
K901334
Hycor Biomedical, Inc.
Toxicology · 53d
Cleared Aug 25, 1989
ADX CANNABINOIDS
K890693
Abbott Laboratories
Toxicology · 196d
Cleared Mar 16, 1989
ABUSCREEN FP FOR CANNABINOIDS
K890887
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Oct 11, 1988
TDX CANNABINOIDS-GS
K883731
Abbott Laboratories
Toxicology · 41d
Cleared Aug 29, 1988
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313
Syva Co.
Toxicology · 87d
Cleared Aug 08, 1988
EMIT HVA CANNABINOID 100 NG ASSAY
K882819
Syva Co.
Toxicology · 31d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
K881814
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015
Abbott Laboratories
Toxicology · 57d
Cleared Feb 03, 1988
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH
K875252
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 43d
Cleared Dec 18, 1987
TDXR DELTA-9-CANNABINOIDS
K874646
Abbott Laboratories
Chemistry · 35d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX CANNABINOIDS
K874488
Abbott Laboratories
Toxicology · 24d
Cleared Nov 20, 1987
REVISED LABELING FOR CANNABINOIDS TEST KIT
K874269
Roche Diagnostic Systems, Inc.
Toxicology · 31d
Cleared Nov 03, 1987
CANNABINOID ENZYME IMMUNOASSAY KIT
K872882
General Diagnostics
Toxicology · 104d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA CANNABINOID ASSAYS
K874079
Syva Co.
Toxicology · 22d
Cleared Oct 28, 1987
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
K874156
Syva Co.
Toxicology · 15d
Cleared Oct 15, 1987
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
K873753
Diagnostic Products Corp.
Toxicology · 41d
Cleared Jun 05, 1987
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
K871695
Diagnostic Products Corp.
Toxicology · 36d
Cleared Mar 16, 1987
ABUSCREEN (R) EIA CANNABINOIDS
K870377
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Mar 13, 1987
TDXR CANNABINOIDS
K864751
Abbott Laboratories
Chemistry · 98d
Cleared Apr 11, 1986
EMIT D.A.U. CANNABINOID 20NG ASSAY
K860500
Syva Co.
Toxicology · 59d
Cleared May 01, 1985
EMIT 700 CANNABINOID 20 ASSAY
K851373
Syva Co.
Toxicology · 23d