FDA 510(k) Toxicology Devices
About Toxicology Devices
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.
3026
Total
3016
Cleared
87d
Avg days
1976
Since
128 Toxicology devices
Cleared
Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
LCM
Enzyme Immunoassay, Phencyclidine
141d
Cleared
Oct 14, 2016
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
DIS
Enzyme Immunoassay, Barbiturate
115d
Cleared
Jun 27, 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
59d
Cleared
Jun 24, 2016
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
DKZ
Enzyme Immunoassay, Amphetamine
330d
Cleared
May 23, 2016
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
JXM
Enzyme Immunoassay, Benzodiazepine
159d
Cleared
Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
LEH
Radioimmunoassay, Vancomycin
90d
Cleared
Mar 18, 2016
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
LAF
Gas Chromatography, Methamphetamine
86d
Cleared
Jan 05, 2016
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
JXM
Enzyme Immunoassay, Benzodiazepine
189d
Cleared
Nov 23, 2015
Wondfo Propoxyphene Urine Test
JXN
Enzyme Immunoassay, Propoxyphene
83d
Cleared
Nov 04, 2015
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
MLM
Enzyme Immunoassay, Tracrolimus
282d
Cleared
Oct 23, 2015
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
DJG
Enzyme Immunoassay, Opiates
227d
Cleared
Sep 09, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
DKZ
Enzyme Immunoassay, Amphetamine
29d
Cleared
Sep 04, 2015
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
LCM
Enzyme Immunoassay, Phencyclidine
31d
Cleared
Aug 18, 2015
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)
LFG
Radioimmunoassay, Tricyclic Antidepressant Drugs
90d
Cleared
Jul 24, 2015
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
DJR
Enzyme Immunoassay, Methadone
59d
Cleared
Jul 01, 2015
Wondfo CR3 Keyless Split Sample Cup
DJG
Enzyme Immunoassay, Opiates
29d
Cleared
Jun 29, 2015
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
84d
Cleared
Jun 05, 2015
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
LDJ
Enzyme Immunoassay, Cannabinoids
31d
Cleared
May 28, 2015
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
LDJ
Enzyme Immunoassay, Cannabinoids
373d
Cleared
May 20, 2015
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
DJG
Enzyme Immunoassay, Opiates
161d
Cleared
Apr 24, 2015
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
DIS
Enzyme Immunoassay, Barbiturate
30d
Cleared
Apr 07, 2015
CR3 Keyless Split Sample Cup Morphine - Methamphetamine
DNK
Thin Layer Chromatography, Morphine
28d
Cleared
Mar 09, 2015
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
DJG
Enzyme Immunoassay, Opiates
33d
Cleared
Mar 04, 2015
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
LAF
Gas Chromatography, Methamphetamine
43d
Cleared
Feb 25, 2015
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
DJG
Enzyme Immunoassay, Opiates
29d
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