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
225 devices
25–48 of 225
Cleared Mar 06, 2014
UCP MULTI-DRUG TEST KEY CUPS
K132812
Ucp Biosciences, Inc.
Toxicology · 178d
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 Jan 15, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP
K131110
Co-Innovation Biotech Co., Ltd.
Toxicology · 271d
Cleared Dec 20, 2013
GENPRIME DRUGS OF ABUSE READER SYSTEM
K130082
Genprime, Inc.
Chemistry · 340d
Cleared Oct 07, 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645
Alfa Scientific Designs, Inc.
Toxicology · 124d
Cleared Jul 19, 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811
Ucp Biosciences, Inc.
Toxicology · 30d
Cleared Jun 17, 2013
Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
K122809
Advin Biotech
Toxicology · 277d
Cleared May 24, 2013
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
K121065
Polymed Therapeutics, Inc.
Toxicology · 413d
Cleared May 15, 2013
UCP HOME DRUG SCREENING TEST
K130463
Ucp Biosciences, Inc.
Toxicology · 82d
Cleared May 02, 2013
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
K130811
Psychemedics Corp.
Toxicology · 38d
Cleared Jan 09, 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K123863
Ucp Biosciences, Inc.
Toxicology · 26d
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 30, 2012
UCP HOME DRUG SCREENING TEST CUPS
K122419
Ucp Biosciences, Inc.
Toxicology · 113d
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 May 17, 2012
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
K121339
Chemtron Biotech, Inc.
Toxicology · 14d
Cleared Nov 10, 2011
AMEDITECH IMMUTEST MILTI-DRUG SCREEN
K113046
Ameditech, Inc.
Toxicology · 28d
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
Cleared Dec 28, 2010
LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY
K102210
Lin-Zhi International, Inc.
Chemistry · 145d
Cleared Jul 28, 2010
AMPHETAMINES II ASSAY
K093664
Roche Diagnostics Corp.
Chemistry · 243d