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.
FDA 510(k) Cleared Enzyme Immunoassay, Amphetamine Devices (Product Code DKZ)
About Product Code DKZ - Regulatory Context
510(k) Submission Activity
225 total 510(k) submissions under product code DKZ since 1976, with 225 receiving FDA clearance (average review time: 111 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under DKZ have taken an average of 233 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.
DKZ devices are reviewed by the Toxicology panel. Browse all Toxicology devices →