DJR · Class II · 21 CFR 862.3620

FDA Product Code DJR: Enzyme Immunoassay, Methadone

Methadone monitoring is essential in opioid use disorder treatment programs. FDA product code DJR covers enzyme immunoassay systems for methadone detection in biological specimens.

These tests use antibody-based technology to screen for methadone and its metabolites in urine, confirming medication adherence in opioid treatment programs and detecting illicit methadone use in forensic and clinical settings.

DJR devices are Class II medical devices, regulated under 21 CFR 862.3620 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Lin-Zhi International, Inc. and Immunalysis Corporation.

3
Total
3
Cleared
75d
Avg days
2015
Since

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

3 devices
1–3 of 3
Cleared Oct 04, 2019
LZI Methadone II Enzyme Immunoassay
K192433
Lin-Zhi International, Inc.
Toxicology · 29d
Cleared Jun 26, 2017
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K170416
Lin-Zhi International, Inc.
Toxicology · 136d
Cleared Jul 24, 2015
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395
Immunalysis Corporation
Toxicology · 59d

How to use this database

This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Methadone devices (product code DJR). 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 →