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 Healgen Scientific, LLC, Lin-Zhi International, Inc. and Immunalysis Corporation.

3
Total
3
Cleared
188d
Avg days
2015
Since

List of Enzyme Immunoassay, Cannabinoids devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Mar 17, 2023
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
K223162
Healgen Scientific, LLC
Toxicology · 161d
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

How to use this database

This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Cannabinoids devices (product code LDJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Toxicology FDA review panel. Browse all Toxicology devices →