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
2619 Toxicology devices
1301–1325 of 2619
Cleared Apr 06, 1994
CEDIA DAU THC CALIBRATORS
K935795 · Microgenics Corp.
DLJ · Calibrators, Drug Specific · 120d
Cleared Apr 05, 1994
CEDIA(R) DAU PCP ASSAY
K935650 · Microgenics Corp.
LCM · Enzyme Immunoassay, Phencyclidine · 133d
Cleared Mar 28, 1994
IL TEST(TM) TRIGLYCERIDE
K931116 · Instrumentation Laboratory CO
JGY · Colorimetric Method, Triglycerides · 389d
Cleared Mar 22, 1994
DRUGS OF ABUSE CONTROLS
K935285 · Medical Diagnostic Technologies, Inc.
DIF · Drug Mixture Control Materials · 139d
Cleared Mar 22, 1994
CEDIA DAU BARBITURATE ASSAY
K936030 · Microgenics Corp.
DIS · Enzyme Immunoassay, Barbiturate · 95d
Cleared Mar 21, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
K934273 · Eastman Kodak Company
DMT · Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet · 202d
Cleared Mar 14, 1994
CEDIA DAU NEGATIVE CALIBRATOR
K935793 · Microgenics Corp.
DKB · Calibrators, Drug Mixture · 97d
Cleared Mar 14, 1994
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
K936028 · Microgenics Corp.
DKB · Calibrators, Drug Mixture · 87d
Cleared Mar 11, 1994
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568 · Baxter Diagnostics, Inc.
DLZ · Enzyme Immunoassay, Phenobarbital · 113d
Cleared Mar 11, 1994
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS
K935904 · Microgenics Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 91d
Cleared Mar 11, 1994
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
K936130 · Roche Diagnostic Systems, Inc.
LGQ · Fluorescence Polarization Immunoassay, Phenobarbital · 78d
Cleared Mar 11, 1994
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
K936131 · Roche Diagnostic Systems, Inc.
LGR · Fluorescence Polarization Immunoassay, Diphenylhydantoin (total) · 78d
Cleared Feb 25, 1994
QMS PHENOBARBITAL
K934388 · Seradyn, Inc.
LFN · Nephelometric Inhibition Immunoassay, Phenobarbital · 169d
Cleared Jan 27, 1994
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844 · Roche Diagnostic Systems, Inc.
LAS · Drug Specific Control Materials · 343d
Cleared Jan 27, 1994
URINE CALIBRATORS AND CONTROLS MODIFICATION
K935101 · Diagnostic Reagents, Inc.
DKB · Calibrators, Drug Mixture · 99d
Cleared Jan 26, 1994
METHADONE ENZYME IMMUNOASSAY
K934667 · Diagnostic Reagents, Inc.
DJR · Enzyme Immunoassay, Methadone · 119d
Cleared Jan 25, 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042 · Roche Diagnostic Systems, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 96d
Cleared Jan 25, 1994
CEDIA DAU 5-DRUG CALIBRATORS
K935792 · Microgenics Corp.
DKB · Calibrators, Drug Mixture · 49d
Cleared Jan 25, 1994
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
K935794 · Microgenics Corp.
DKB · Calibrators, Drug Mixture · 49d
Cleared Jan 13, 1994
ALKO FLUIDS PACKS FOR NOVA ANALYZERS
K930199 · Alko Diagnostic Corp.
JIX · Calibrator, Multi-analyte Mixture · 364d
Cleared Jan 13, 1994
AMPHETAMINES EIA ASSAY MODIFICATION
K934891 · Diagnostic Reagents, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 114d
Cleared Jan 13, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591 · Microgenics Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 55d
Cleared Jan 11, 1994
CEDIA(R) DAU OPIATE ASSAY
K935346 · Microgenics Corp.
DJG · Enzyme Immunoassay, Opiates · 67d
Cleared Jan 06, 1994
EMIT(R) IIC OPIATE ASSAY
K935117 · Syva Co.
DJG · Enzyme Immunoassay, Opiates · 71d
Cleared Jan 03, 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · Syva Co.
DIF · Drug Mixture Control Materials · 63d

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All categories 2619 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