FDA Review Panel · TX

FDA 510(k) Toxicology Devices

FDA 510(k) Toxicology Devices - Regulatory Overview

FDA 510(k) toxicology devices include diagnostic systems for detecting drugs, poisons and toxic substances in biological samples. The FDA review panel code is TX.

Main categories:

  • Drug screening assays - urine and oral fluid panels for workplace and clinical use
  • Therapeutic drug monitoring (TDM) - immunosuppressants, antibiotics, anticonvulsants
  • Heavy metal testing - lead, mercury, arsenic and cadmium detection systems
  • Alcohol testing devices - breathalyzers and ethanol assays for clinical use

Most toxicology devices are Class II under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.

3028
Total
3018
Cleared
95d
Avg (2y)
1976
Since
2616 Toxicology devices
526–550 of 2616
Cleared Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
K032049 · Roche Diagnostics Corp.
LEG · Enzyme Immunoassay, Valproic Acid · 51d
Cleared Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
K031990 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 54d
Cleared Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
K031856 · Roche Diagnostics Corp.
DKB · Calibrators, Drug Mixture · 51d
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.
DKZ · Enzyme Immunoassay, Amphetamine · 59d
Cleared Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · Dade Behring, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 70d
Cleared Jul 15, 2003
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
K031044 · Clinical Data, Inc.
KNK · Acid, Uric, Uricase (colorimetric) · 105d
Cleared Jul 15, 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870 · Beckman Coulter, Inc.
LEG · Enzyme Immunoassay, Valproic Acid · 28d
Cleared Jul 14, 2003
VERDICT II, PROFILE II
K031032 · Medtox Diagnostics, Inc.
DJG · Enzyme Immunoassay, Opiates · 104d
Cleared Jul 01, 2003
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392 · Medical Analysis Systems, Inc.
DKC · Alcohol Control Materials · 60d
Cleared Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004 · Dade Behring, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 67d
Cleared May 22, 2003
DRI COTININE EIA ASSAY
K030649 · Microgenics Corp.
MRS · Test System, Nicotine, Cotinine, Metabolites · 83d
Cleared May 22, 2003
'RAPID ONE' - PROPOXYPHENE TEST
K030835 · American Bio Medica Corp.
JXN · Enzyme Immunoassay, Propoxyphene · 66d
Cleared May 06, 2003
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
K023648 · Sun Biomedical Laboratories, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 188d
Cleared Apr 30, 2003
'RAPIDTEC'-5M-MULTIPLE DIP TEST
K023869 · American Bio Medica Corp.
DJR · Enzyme Immunoassay, Methadone · 161d
Not Cleared Apr 30, 2003
NIOX ARTICLE NO: 02-1000
DEN030001 · Aerocrine AB
MXA · System, Test, Breath Nitric Oxide · 43d
Cleared Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
K031002 · Beckman Coulter, Inc.
DJG · Enzyme Immunoassay, Opiates · 29d
Cleared Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
K030428 · Roche Diagnostics Corp.
DIP · Enzyme Immunoassay, Diphenylhydantoin · 77d
Cleared Apr 14, 2003
AT HOME DRUG CUP, MODEL 9150X
K030447 · Phamatech
MVO · Kit, Test, Multiple, Drugs Of Abuse, Over The Counter · 62d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213 · Roche Diagnostics Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 80d
Cleared Apr 03, 2003
PRECISET DAT AMPHETAMINE
K030826 · Quantimetrix Corp.
DIJ · Lead, Delta Amino Levulinic Acid · 20d
Cleared Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · Microgenics Corp.
LAS · Drug Specific Control Materials · 33d
Cleared Feb 11, 2003
WAKO NEFA LINEARITY SET
K030065 · Wako Chemicals USA, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 35d
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780 · Microgenics Corp.
DLJ · Calibrators, Drug Specific · 90d
Cleared Feb 05, 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
K023946 · ACON Laboratories, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 70d
Cleared Jan 21, 2003
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
K023795 · Lin-Zhi International, Inc.
JXN · Enzyme Immunoassay, Propoxyphene · 69d

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All categories 2616 DJG Enzyme Immunoassay, Opiates 167 DKZ Enzyme Immunoassay, Amphetamine 165 DIF Drug Mixture Control Materials 131 LDJ Enzyme Immunoassay, Cannabinoids 115 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 106 DLJ Calibrators, Drug Specific 97 DIS Enzyme Immunoassay, Barbiturate 87 JXM Enzyme Immunoassay, Benzodiazepine 79 DKB Calibrators, Drug Mixture 76 LCM Enzyme Immunoassay, Phencyclidine 67 LAS Drug Specific Control Materials 63 KXT Enzyme Immunoassay, Digoxin 56 DJR Enzyme Immunoassay, Methadone 52 KLS Enzyme Immunoassay, Theophylline 44 KLT Enzyme Immunoassay, Carbamazepine 40