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
90d
Avg (2y)
1976
Since
2046 Toxicology devices
426–450 of 2046
Cleared Jan 15, 2002
RANDOX VALPROIC ACID
K011649 · Randox Laboratories, Ltd.
LEG · Enzyme Immunoassay, Valproic Acid · 231d
Cleared Jan 11, 2002
RANDOX DIGITOXIN
K012112 · Randox Laboratories, Ltd.
LFM · Enzyme Immunoassay, Digitoxin · 189d
Cleared Jan 10, 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
K012745 · Biosite Incorporated
DKZ · Enzyme Immunoassay, Amphetamine · 147d
Cleared Jan 08, 2002
ROCHE ACETAMINOPHEN
K013757 · Roche Diagnostics Corp.
LDP · Colorimetry, Acetaminophen · 56d
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · Roche Diagnostics Corp.
DJG · Enzyme Immunoassay, Opiates · 63d
Cleared Dec 21, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
K013900 · Ortho-Clinical Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d
Cleared Dec 18, 2001
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380 · ACON Laboratories, Inc.
DJG · Enzyme Immunoassay, Opiates · 67d
Cleared Dec 14, 2001
ETHANOL
K013538 · Abbott Laboratories
DML · Nad-nadh, Specific Reagent For Alcohol Enzyme Method · 51d
Cleared Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · Beckman Coulter, Inc.
LEH · Radioimmunoassay, Vancomycin · 89d
Cleared Dec 04, 2001
RANDOX PHENYTOIN
K011393 · Randox Laboratories, Ltd.
DIP · Enzyme Immunoassay, Diphenylhydantoin · 211d
Cleared Nov 09, 2001
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824 · ACON Laboratories, Inc.
DIS · Enzyme Immunoassay, Barbiturate · 78d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396 · Roche Diagnostics Corp.
DKZ · Enzyme Immunoassay, Amphetamine · 101d
Cleared Oct 15, 2001
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
K012595 · ACON Laboratories, Inc.
DJR · Enzyme Immunoassay, Methadone · 66d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
K012999 · Biosite Incorporated
DIF · Drug Mixture Control Materials · 27d
Cleared Oct 03, 2001
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
K013002 · Biosite Incorporated
DIF · Drug Mixture Control Materials · 27d
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

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All categories 2046 DJG Enzyme Immunoassay, Opiates 122 DIF Drug Mixture Control Materials 104 DKZ Enzyme Immunoassay, Amphetamine 103 DLJ Calibrators, Drug Specific 84 LDJ Enzyme Immunoassay, Cannabinoids 78 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 72 DKB Calibrators, Drug Mixture 68 JXM Enzyme Immunoassay, Benzodiazepine 66 DIS Enzyme Immunoassay, Barbiturate 65 KXT Enzyme Immunoassay, Digoxin 50 LAS Drug Specific Control Materials 49 LCM Enzyme Immunoassay, Phencyclidine 48 DJR Enzyme Immunoassay, Methadone 45 KLS Enzyme Immunoassay, Theophylline 41 DIP Enzyme Immunoassay, Diphenylhydantoin 32