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 14, 2014
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
K141532
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 34d
Cleared Feb 25, 2014
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared Feb 04, 2014
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653
Lin-Zhi International, Inc.
Toxicology · 244d
Cleared Oct 07, 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645
Alfa Scientific Designs, Inc.
Toxicology · 124d
Cleared Dec 21, 2012
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
K122961
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 87d
Cleared Nov 15, 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
K122904
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 55d
Cleared Aug 01, 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
K121987
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 26d
Cleared Jul 15, 2011
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST
K111560
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 42d
Cleared May 03, 2011
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
K110446
Roche Diagnostics
Toxicology · 76d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
K101745
Microgenics Corp.
Chemistry · 290d
Cleared Mar 01, 2011
RANDOX ECSTASY (MDMA) ASSAY
K092275
Randox Laboratories, Ltd.
Chemistry · 581d

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 →