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.

3029
Total
3019
Cleared
95d
Avg (2y)
1976
Since
3029 Toxicology devices
1126–1150 of 3029
Cleared Jul 30, 1997
SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS
K972132 · Sigma Diagnostics, Inc.
LEG · Enzyme Immunoassay, Valproic Acid · 54d
Cleared Jul 24, 1997
CEDIA DIGOXIN CALIBRATORS
K972433 · Boehringer Mannheim Corp.
DLJ · Calibrators, Drug Specific · 24d
Cleared Jul 22, 1997
OPUS ETHANOL
K972011 · Behring Diagnostics, Inc.
DIC · Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method · 53d
Cleared Jul 14, 1997
QUIKSTRIP ONE STEP COCAINE TEST
K971926 · Drial Consultants, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 48d
Cleared Jul 14, 1997
INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
K972330 · Oxis Intl., Inc.
LGQ · Fluorescence Polarization Immunoassay, Phenobarbital · 21d
Cleared Jul 03, 1997
ONE STEP MARIJUANA CARD TEST
K970548 · Teco Diagnostics
LDJ · Enzyme Immunoassay, Cannabinoids · 141d
Cleared Jul 03, 1997
ONE STEP MORPHINE CARD TEST
K970579 · Teco Diagnostics
DNK · Thin Layer Chromatography, Morphine · 139d
Cleared Jun 26, 1997
QUIKSTRIP ONE STEP METHAMPHETAMINE
K970395 · Drial Consultants, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 143d
Cleared Jun 25, 1997
EMIT II OPIATES 300/2000 ASSAY
K971596 · Behring Diagnostics, Inc.
DJG · Enzyme Immunoassay, Opiates · 55d
Cleared Jun 25, 1997
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
K971600 · Behring Diagnostics, Inc.
DKB · Calibrators, Drug Mixture · 55d
Cleared Jun 25, 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
K971841 · Bionike Laboratories, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 37d
Cleared Jun 24, 1997
LYPHOCHEK REMEDI CONTROL
K972174 · Bio-Rad
DIF · Drug Mixture Control Materials · 15d
Cleared Jun 11, 1997
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · Bayer Corp.
LAN · Enzyme Immunoassay, N-acetylprocainamide · 33d
Cleared Jun 06, 1997
AQ OPIATES (MORPHINE) TEST
K971361 · Bionike Laboratories, Inc.
DJG · Enzyme Immunoassay, Opiates · 56d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
K971506 · Beckman Instruments, Inc.
DMT · Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet · 39d
Cleared May 30, 1997
QUIKSTRIP ONE STEP AMPHETAMINE TEST
K971218 · Drial Consultants, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 58d
Cleared May 30, 1997
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
K971691 · Bio-Rad
DIF · Drug Mixture Control Materials · 23d
Cleared May 21, 1997
CEDIA DIGOXIN II
K970883 · Boehringer Mannheim Corp.
KXT · Enzyme Immunoassay, Digoxin · 72d
Cleared May 21, 1997
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
K971534 · Beckman
DIF · Drug Mixture Control Materials · 23d
Cleared May 14, 1997
CEDIA DIGOXIN
K970881 · Boehringer Mannheim Corp.
KXT · Enzyme Immunoassay, Digoxin · 65d
Cleared May 14, 1997
QUIKPAC II ONE STEP AMPHETAMINE TEST
K971109 · Drial Consultants, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 49d
Cleared May 13, 1997
QUICKPAC II ONE STEP METHAMPHETAMINE TEST
K970724 · Drial Consultants, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 75d
Cleared May 12, 1997
INNOFLOUR CALIBRATOR REAGENT SET
K970509 · Oxis Intl., Inc.
DLJ · Calibrators, Drug Specific · 90d
Cleared May 12, 1997
INNOFLOUR TOPIRAMATE REAGENT SET
K970510 · Oxis Intl., Inc.
MSL · System, Test, Topiramatee · 90d
Cleared May 12, 1997
INNOFLUOR TOPIRAMATE CONTROL SET
K970517 · Oxis Intl., Inc.
LAS · Drug Specific Control Materials · 90d

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All categories 3029 DKZ Enzyme Immunoassay, Amphetamine 191 DJG Enzyme Immunoassay, Opiates 188 DIF Drug Mixture Control Materials 148 LDJ Enzyme Immunoassay, Cannabinoids 136 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 131 DLJ Calibrators, Drug Specific 108 DIS Enzyme Immunoassay, Barbiturate 95 JXM Enzyme Immunoassay, Benzodiazepine 83 DKB Calibrators, Drug Mixture 81 LCM Enzyme Immunoassay, Phencyclidine 78 LAS Drug Specific Control Materials 75 KXT Enzyme Immunoassay, Digoxin 62 DJR Enzyme Immunoassay, Methadone 56 KLS Enzyme Immunoassay, Theophylline 50 KLT Enzyme Immunoassay, Carbamazepine 43