# K153192: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests

- Pathway: 510(k) (Traditional)
- Applicant: Chemtron Biotech, Inc.
- Decided: Apr 18, 2016 after 167 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K964355 (1996). 44 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061718: Innovacon Spectrum II Test Card, Innovacon, Inc. (2006) Summary page 12.
- K103295: Quickscreen Cocaine 150 Screening Test, Phamatech, Inc. (2012) Summary page 16.
- K060896: Modification to Ontrak Testcup II and Onsite Cupkit, Varian, Inc. (2006) Summary page 12.

## Most influential descendants
- K232736: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test (2023), 1 descendant of its own
- K252684: Labcorp Fentanyl Urine Visual Test (2026), 0 descendants of its own

## Indications for use
The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL) Amphetamine AMP d-Amphetamine 300 ‘ Amphetamine AMP d-Amphetamine 500 Amphetamine AMP d-Amphetamine 1000 Barbiturates BAR Secobarbital/Pentobarbital 200 Barbiturates BAR Secobarbital/Pentobarbital 300 Benzodiazepines BZO Oxazepam 200 Benzodiazepines BZO Oxazepam 300 Buprenorphine BUP Buprenorphine 10 Cocaine CcoC Benzoylecgonine 150 Cocaine COC Benzoylecgonine 300 Ecstasy MDMA d,l-Methylenedioxy methamphetamine 500 Methamphetamine MAMP d-Methamphetamine 300 Methamphetamine MAMP d-Methamphetamine 500 Methamphetamine MAMP d-Methamphetamine 1000 Marijuana THC 11-nor-A9-THC-9-COOH 50 Methadone MTD Methadone 300 Opiates OPI Morphine 2000 Oxycodone OXY Oxycodone 100 Phencyclidine PCP Phencyclidine 25 Propoxyphene PPX Propoxyphene 300 Tricyclic Antidepressants TCA Nortriptyline 1000 The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine. The Chemtrue® Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL) Amphetamine AMP d-Amphetamine 300 Amphetamine AMP d-Amphetamine 500 Amphetamine AMP d-Amphetamine 1000 Barbiturates BAR Secobarbital/Pentobarbital 200 Barbiturates BAR Secobarbital/Pentobarbital 300 Benzodiazepines BZO Oxazepam 200 Benzodiazepines BZO Oxazepam 300 Buprenorphine BUP. Buprenorphine 10 Cocaine COC Benzoylecgonine 150 Cocaine CcoC Benzoylecgonine 300 Ecstasy MDMA d,l-Methylenedioxy methamphetamine 500 Methamphetamine MAMP d-Methamphetamine 300 Methamphetamine MAMP d-Methamphetamine 500 Methamphetamine MAMP d-Methamphetamine 1000 Marijuana THC 11-nor-A9-THC-9-COOH 50 Methadone MTD Methadone 300 Morphine MOR Morphine 300 Oxycodone oXY Oxycodone 100 Phencyclidine PCP Phencyclidine 25 Propoxyphene PPX Propoxyphene 300 Tricyclic Antidepressants ~ TCA Nortriptyline 1000 The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LLC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine. The Chemtrue® Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL) Amphetamine AMP d-Amphetamine - 300 Amphetamine AMP d-Amphetamine 500 Amphetamine AMP d-Amphetamine 1000 Barbiturates BAR Secobarbital/Pentobarbital 200 Barbiturates BAR Secobarbital/Pentobarbital 300 Benzodiazepines BZO Oxazepam 200 Benzodiazepines BZO Oxazepam 300 Buprenorphine BUP Buprenorphine 10 Cocaine cocC Benzoylecgonine C 150 Cocaine CcOC Benzoylecgonine 300 Ecstasy MDMA d,lI-Methylenedioxy methamphetamine 500 Methamphetamine MAMP d-Methamphetamine 300 Methamphetamine MAMP d-Methamphetamine 500 Methamphetamine MAMP d-Methamphetamine 1000 Marijuana THC 11-nor-A9-THC-9-COOH 50 Methadone MTD Methadone 300 Opiates OPI Morphine 2000 Oxycodone OXY Oxycodone 100 Phencyclidine PGP Phencyclidine 25 Propoxyphene PPX.. Propoxyphene 300 Tricyclic Antidepressants TCA Nortriptyline 1000 The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine. The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte Abbreviation Calibrator Cutoff Concentration (ng/mL) Amphetamine AMP d-Amphetamine 300 Amphetamine AMP d-Amphetamine 500 Amphetamine AMP d-Amphetamine 1000 Barbiturates BAR Secobarbital/Pentobarbital 200 Barbiturates BAR Secobarbital/Pentobarbital 300 Benzodiazepines BZO Oxazepam 200 ‘Benzodiazepines BZO Oxazepam 300 Buprenorphine BUP Buprenorphine 10 Cocaine COC Benzoylecgonine 150 Cocaine CcOoC Benzoylecgonine 300 Ecstasy MDMA d,l-Methylenedioxy methamphetamine 500 Methamphetamine MAMP d-Methamphetamine 300 Methamphetamine MAMP d-Methamphetamine 500 Methamphetamine MAMP d-Methamphetamine 1000 Marijuana THC 11-nor-A9-THC-9-COOH 50 Methadone MTD - Methadone 300 Morphine MOR Morphine 300 Oxycodone OXY Oxycodone 100 Phencyclidine PCP Phencyclidine 25 Propoxyphene PPX Propoxyphene 300 Tricyclic Antidepressants TCA Nortriptyline 1000 The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.

Source page: https://510kreport.com/device/K153192
Methodology: https://510kreport.com/methodology