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 Roche Diagnostics 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 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 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 Feb 06, 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
K143500
Immunalysis Corporation
Toxicology · 58d
Cleared Jul 28, 2010
AMPHETAMINES II ASSAY
K093664
Roche Diagnostics Corp.
Chemistry · 243d
Cleared Feb 03, 2010
AMPHETAMINES II
K083764
Roche Diagnostics Corp.
Chemistry · 412d
Cleared May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337
Dade Behring, Inc.
Chemistry · 169d
Cleared Jan 07, 2005
EMIT II PLUS ECSTASY ASSAY
K043028
Dade Behring, Inc.
Toxicology · 65d
Cleared Apr 08, 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133
Dade Behring, Inc.
Chemistry · 78d
Cleared Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004
Dade Behring, Inc.
Toxicology · 67d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257
Syva Co.
Chemistry · 16d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417
Roche Diagnostics Corp.
Toxicology · 55d

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 →