510(k) · Cleared
ClearedChemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemtron Biotech, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Apr 18, 2016 as substantially equivalent to K061718 (Innovacon, Inc., 2006) and 2 other predicates after a 167-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it.
- Decided
- Apr 18, 2016
- Review
- 167 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K964355 (1996). 44 ancestors in all, the oldest K881816 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK964355 Ontrak Testcup 5 (Modification)Roche Diagnostic Systems, Inc. · 1996
- 4 generations backK990337 Ontrak Testcup-5 M2KRoche Diagnostics Corp. · 1999
- 3 generations backK994017 Ontrak Testcup 5 M2K, Cat. 11 1850 1Roche Diagnostics Corp. · 2000
- 2 generations backK033902 Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004
- 1 generation backK060896 Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006
- This deviceK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252684 Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K964355 | Ontrak Testcup 5 (Modification) | Roche Diagnostic Systems, Inc. | 1996 | — |
| −4 | K990337 | Ontrak Testcup-5 M2K | Roche Diagnostics Corp. | 1999 | — |
| −3 | K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1 | Roche Diagnostics Corp. | 2000 | — |
| −2 | K033902 | Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2004 | — |
| −1 | K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2006 | — |
| 0 (this device) | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| +1 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
| +2 | K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 4 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061718 | Innovacon Spectrum II Test CardSummary page 12…drugs test system. 1 C. PREDICATE DEVICES C-1. k061718: Innovacon Spectrum II Test Card with Integrated Cups, applicant: Innovacon Laboratories, Inc. C-2. k10329: Quic… | 2006 |
| * | K103295 | Quickscreen Cocaine 150 Screening TestSummary page 16…ces Item Candidate Devices Predicate Devices (k061718, k103295 and k060896) For qualitative detection of drugs of abuse in… | 2012 |
| * | K060896 | Modification to Ontrak Testcup II and Onsite CupkitSummary page 12…ectrum II Test Card with Integrated Cups, applicant: Innovacon Laboratories, Inc. C-2. k10329: QuickScreenTM Test. The applicant: Phamatech, Inc. C-3. k060896: ONSite CupKitTM. The applicant: Variance, Inc. D. INDICATIONS FOR USE: Chemtrue® Multi-Panel Drug Screen Cup with OPI 2000 Te… | 2006 |
| † | K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests | 2014 |
| † | K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 44 ancestors have a recall of any class.
- Of its descendants, K232736 (Chemtron Biotech, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K061718.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
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…
Read the full statement (1,145 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153192: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153192
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026