DKZ · Class II · 21 CFR 862.3100

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 Roche Diagnostic Systems, Inc., Syva Co. and American Bio Medica Corp..

225
Total
225
Cleared
111d
Avg days
1976
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 233d recently vs 111d historically

FDA 510(k) Cleared Enzyme Immunoassay, Amphetamine Devices (Product Code DKZ)

225 devices
1–24 of 225
Cleared Oct 30, 2024
DRI Ecstasy Plus Assay
K240670
Microgenics Corporation
Toxicology · 233d
Cleared Dec 13, 2023
AllTest Multi-Drug Rapid Test Cup
K233019
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 82d
Cleared May 19, 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137
Xenta Biomedical Science Co., Ltd.
Toxicology · 28d
Cleared Mar 11, 2020
Quidel Triage® TOX Drug Screen, 94600
K200363
Quidel Cardiovascular, Inc.
Toxicology · 26d
Cleared Oct 03, 2019
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099
Atlas Medical
Toxicology · 161d
Cleared Jun 19, 2019
Quidel Triage TOX Drug Screen, 94600
K182719
Quidel Cardiovascular, Inc.
Toxicology · 264d
Cleared Mar 27, 2019
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
K182738
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 180d
Cleared Dec 14, 2018
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
K180879
Shanghai Venture Bio-Tech Co., Ltd.
Toxicology · 255d
Cleared Oct 18, 2018
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
K181945
Phamatech, Inc.
Toxicology · 90d
Cleared Feb 23, 2018
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
K173303
Alfa Scientific Designs, Inc.
Toxicology · 128d
Cleared Aug 30, 2016
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
K161251
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 119d
Cleared Jun 24, 2016
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
K152122
Alfa Scientific Designs, Inc.
Toxicology · 330d
Cleared May 03, 2016
UCP COMPACT DRUG TESTS
K152908
Ucp Biosciences, Inc.
Toxicology · 215d
Cleared Apr 15, 2016
ACCU NEWS Drug Screening Test Card/Urine Cup
K152590
Coretests, Inc.
Toxicology · 218d
Cleared Mar 31, 2016
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)
K153465
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 121d
Cleared Sep 09, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
K152269
Healgen Scientific, LLC
Toxicology · 29d
Cleared Aug 21, 2015
UCP Drug Test Mini Cups
K151213
Ucp Biosciences, Inc.
Toxicology · 107d
Cleared Jul 28, 2015
Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
K142855
Omega Laboratories, Inc.
Toxicology · 301d
Cleared May 20, 2015
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET
K141748
Biophor Diagnostics, Inc.
Toxicology · 324d
Cleared Feb 06, 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
K143500
Immunalysis Corporation
Toxicology · 58d
Cleared Dec 11, 2014
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
K142800
Co-Innovation Biotech Co., Ltd.
Toxicology · 73d
Cleared Dec 01, 2014
Chemtrue Multi-Panel DOA DIP Card Tests
K142580
Chemtron Biotech, Inc.
Toxicology · 77d
Cleared Jul 14, 2014
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
K141532
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 34d
Cleared May 14, 2014
QUICKSCREEN AMPHETINE 500 TEST
K131069
Phamatech, Inc.
Toxicology · 392d

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 510(k) Review Time - DKZ Product Code

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 →