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
626–650 of 2618
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · Diagnostic Products Corp.
KXT · Enzyme Immunoassay, Digoxin · 61d
Cleared Sep 18, 2001
RANDOX GENTAMICIN
K012978 · Randox Laboratories, Ltd.
LCD · Enzyme Immunoassay, Gentamicin · 74d
Cleared Sep 17, 2001
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · ACON Laboratories, Inc.
JXM · Enzyme Immunoassay, Benzodiazepine · 59d
Cleared Sep 12, 2001
RANDOX THERAPEUTIC DRUG CALIBRATOR
K012318 · Randox Laboratories, Ltd.
DKB · Calibrators, Drug Mixture · 51d
Cleared Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
K012109 · Microgenics Corp.
DLJ · Calibrators, Drug Specific · 52d
Cleared Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · Microgenics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 52d
Cleared Aug 20, 2001
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · Diagnostic Products Corp.
KLB · Radioimmunoassay, Tobramycin · 28d
Cleared Aug 13, 2001
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
K011878 · Syva Co.
DKJ · Colorimetry, Salicylate · 59d
Cleared Aug 09, 2001
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
K011730 · ACON Laboratories, Inc.
LCM · Enzyme Immunoassay, Phencyclidine · 65d
Cleared Jul 31, 2001
SUREVUE URINE HCG
K010522 · Sa Scientific, Inc.
JHI · Visual, Pregnancy Hcg, Prescription Use · 159d
Cleared Jul 31, 2001
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
K011672 · ACON Laboratories, Inc.
LAF · Gas Chromatography, Methamphetamine · 62d
Cleared Jul 31, 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
K011673 · ACON Laboratories, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 62d
Cleared Jul 30, 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353 · ACON Laboratories, Inc.
DJG · Enzyme Immunoassay, Opiates · 88d
Cleared Jul 25, 2001
RAPID DRUG SCREEN
K012159 · American Bio Medica Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 33d
Cleared Jul 17, 2001
VISUALINE AMPHETAMINE DIPSTRIP ASSAY
K011499 · Sun Biomedical Laboratories, Inc.
DKZ · Enzyme Immunoassay, Amphetamine · 63d
Cleared Jul 09, 2001
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841 · ACON Laboratories, Inc.
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 110d
Cleared Jul 02, 2001
RANDOX DIGOXIN
K011302 · Randox Laboratories, Ltd.
KXT · Enzyme Immunoassay, Digoxin · 63d
Cleared Jul 02, 2001
RANDOX PHENOBARBITAL
K011303 · Randox Laboratories, Ltd.
DLZ · Enzyme Immunoassay, Phenobarbital · 63d
Cleared Jul 02, 2001
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
K011920 · Syva Co., Dade Behring, Inc.
KXT · Enzyme Immunoassay, Digoxin · 12d
Cleared Jul 02, 2001
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · Syva Co.
LEG · Enzyme Immunoassay, Valproic Acid · 11d
Cleared Jun 25, 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · Teco Diagnostics
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 151d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · Microgenics Corp.
DJG · Enzyme Immunoassay, Opiates · 65d
Cleared Jun 18, 2001
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
K011620 · Syva Co., Dade Behring, Inc.
LAN · Enzyme Immunoassay, N-acetylprocainamide · 24d
Cleared Jun 12, 2001
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
K011605 · Syva Co., Dade Behring, Inc.
LBZ · Enzyme Immunoassay, Quinidine · 19d
Cleared Jun 08, 2001
VERDICT -II TCA, VERDICT-II MTD
K011545 · Medtox Diagnostics, Inc.
LFG · Radioimmunoassay, Tricyclic Antidepressant Drugs · 21d

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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