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 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
Cleared May 12, 2010
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114
Microgenics Corp.
Chemistry · 223d
Cleared Feb 03, 2010
AMPHETAMINES II
K083764
Roche Diagnostics Corp.
Chemistry · 412d
Cleared Nov 22, 2006
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077
Ortho-Clinical Diagnostics, Inc.
Chemistry · 124d
Cleared Oct 30, 2006
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS
K063024
Lin-Zhi International, Inc.
Chemistry · 28d
Cleared May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337
Dade Behring, Inc.
Chemistry · 169d
Cleared Oct 21, 2005
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
K051579
Immunalysis Corporation
Toxicology · 129d
Cleared Jan 07, 2005
EMIT II PLUS ECSTASY ASSAY
K043028
Dade Behring, Inc.
Toxicology · 65d
Cleared Sep 16, 2004
ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE
K041822
ACON Laboratories, Inc.
Chemistry · 72d
Cleared Sep 09, 2004
ACON TRI-FECT DRUG SCREEN TEST DEVICE
K041743
ACON Laboratories, Inc.
Toxicology · 73d
Cleared Aug 30, 2004
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE
K041685
ACON Laboratories, Inc.
Toxicology · 69d
Cleared May 12, 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350
Randox Laboratories, Ltd.
Toxicology · 90d
Cleared Apr 08, 2004
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
K040133
Dade Behring, Inc.
Chemistry · 78d
Cleared Dec 19, 2003
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
K033094
Lin-Zhi International, Inc.
Toxicology · 81d
Cleared Aug 04, 2003
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD
K031759
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004
Dade Behring, Inc.
Toxicology · 67d
Cleared Aug 30, 2002
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
K022564
Alfa Scientific Designs, Inc.
Toxicology · 28d
Cleared Jun 04, 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
K020395
Lin-Zhi International, Inc.
Toxicology · 118d
Cleared Jun 03, 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247
Biosite Incorporated
Toxicology · 159d
Cleared Jan 10, 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
K012745
Biosite Incorporated
Toxicology · 147d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110
Microgenics Corp.
Toxicology · 52d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257
Syva Co.
Chemistry · 16d