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
1001–1025 of 2618
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
Cleared May 12, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971236 · Greiner America, Inc.
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 40d
Cleared May 08, 1997
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
K971287 · Beckman Instruments, Inc.
DKB · Calibrators, Drug Mixture · 31d
Cleared Apr 28, 1997
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp.
LDJ · Enzyme Immunoassay, Cannabinoids · 210d
Cleared Apr 25, 1997
PARAMAX SALICYLATE REAGENT
K964715 · Dade Intl., Inc.
DKJ · Colorimetry, Salicylate · 151d
Cleared Apr 17, 1997
SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS
K971210 · Beckman Instruments, Inc.
LAS · Drug Specific Control Materials · 15d
Cleared Apr 14, 1997
RAPID DRUG SCREEN
K964900 · American Bio Medica Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 138d
Cleared Apr 08, 1997
IMMULITE COCAINE METABOLITE
K963918 · Diagnostic Products Corp.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 190d
Cleared Apr 08, 1997
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
K970265 · Drial Consultants, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 75d
Cleared Mar 10, 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · Diagnostic Products Corp.
DJG · Enzyme Immunoassay, Opiates · 266d
Cleared Feb 28, 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · Syntron Bioresearch, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 169d
Cleared Feb 20, 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · Drial Consultants, Inc.
LDJ · Enzyme Immunoassay, Cannabinoids · 189d

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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