FDA Product Code DKZ: Enzyme Immunoassay, Amphetamine
Amphetamine detection is critical in emergency toxicology, workplace safety, and substance abuse treatment programs. FDA product code DKZ covers enzyme immunoassay systems for amphetamine detection in biological specimens.
These tests use antibody-based technology to screen for amphetamines and methamphetamines in urine, providing a rapid initial result that guides clinical management and triggers confirmatory testing when positive.
DKZ devices are Class II medical devices, regulated under 21 CFR 862.3100 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Alfa Scientific Designs, Inc., Immunalysis Corporation and Healgen Scientific, LLC.
List of Enzyme Immunoassay, Amphetamine devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Amphetamine devices (product code DKZ). 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 →