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
25–48 of 150
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 Jul 13, 2004
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
K041221
Accu-Stat Diagnostics, Inc.
Toxicology · 64d
Cleared May 06, 2003
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
K023648
Sun Biomedical Laboratories, Inc.
Toxicology · 188d
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 May 17, 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300
Syva Co., Dade Behring, Inc.
Toxicology · 17d
Cleared Mar 15, 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557
ACON Laboratories, Inc.
Toxicology · 118d
Cleared Feb 14, 2001
PROFILE II ER
K010138
Medtox Diagnostics, Inc.
Toxicology · 28d
Cleared Jan 26, 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375
OraSure Technologies, Inc.
Toxicology · 175d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST (THC)
K993663
Worldwide Medical Corp.
Toxicology · 238d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 3
K994138
Worldwide Medical Corp.
Toxicology · 199d
Cleared Jun 23, 2000
FIRST CHECK HOME DRUG TEST PANEL 2
K994139
Worldwide Medical Corp.
Toxicology · 199d
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
Cleared Apr 06, 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461
Dade Behring, Inc.
Toxicology · 55d
Cleared Feb 04, 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131
Phamatech
Toxicology · 17d
Cleared Jan 24, 2000
RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
K993961
American Bio Medica Corp.
Toxicology · 63d
Cleared Jan 18, 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984
Syva Co.
Toxicology · 55d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9078
K994220
Phamatech
Toxicology · 15d
Cleared Dec 27, 1999
SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
K992949
Drug Detection Devices, Ltd.
Toxicology · 117d