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
2618 Toxicology devices
976–1000 of 2618
Cleared Sep 02, 1997
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
K972556 · Phamatech
LAF · Gas Chromatography, Methamphetamine · 55d
Cleared Aug 28, 1997
QUIKPAC II ONE STEP COCAINE TEST
K972059 · Drial Consultants, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 87d
Cleared Aug 28, 1997
50NG/ML COCAINE METABOLITE CALIBRATOR
K972835 · Diagnostic Reagents, Inc.
DLJ · Calibrators, Drug Specific · 28d
Cleared Aug 20, 1997
QUIKSTRIP ONE STEP OPIATES TEST
K972571 · Drial Consultants, Inc.
DJG · Enzyme Immunoassay, Opiates · 41d
Cleared Aug 20, 1997
QUICK SCREEN ONE STEP AMPHETAMINE TEST
K972577 · Phamatech
DIT · Thin Layer Chromatography, Amphetamine · 41d
Cleared Aug 20, 1997
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · Phamatech
DJG · Enzyme Immunoassay, Opiates · 40d
Cleared Aug 13, 1997
VIGIL TDM CONTROLS
K972819 · Beckman Instruments, Inc.
DIF · Drug Mixture Control Materials · 15d
Cleared Aug 12, 1997
VISUALINE II METHAMPHETIMINE
K972032 · Sun Biomedical Laboratories, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 71d
Cleared Aug 08, 1997
QUIKPAC II ONE STEP OPIATE TEST
K972405 · Drial Consultants, Inc.
DJG · Enzyme Immunoassay, Opiates · 43d
Cleared Aug 08, 1997
QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
K972618 · Phamatech
DMN · Thin Layer Chromatography, Cocaine · 28d
Cleared Aug 06, 1997
AQ ONE STEP COCAINE TEST
K972384 · Bionike Laboratories, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 41d
Cleared Aug 04, 1997
METHADONE EIA ASSAY
K972526 · Diagnostic Reagents, Inc.
DJR · Enzyme Immunoassay, Methadone · 39d
Cleared Aug 01, 1997
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K972331 · Oxis Intl., Inc.
LGQ · Fluorescence Polarization Immunoassay, Phenobarbital · 39d
Cleared Jul 31, 1997
DIGOXIN DG-II FPIA REAGENT SET
K972794 · Sigma Diagnostics, Inc.
KXT · Enzyme Immunoassay, Digoxin · 55d
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

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All categories 2618 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