510(k) · Cleared
ClearedChemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
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 17, 2015 as substantially equivalent to K061718 (Innovacon, Inc., 2006) and 1 other predicate after a 120-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Apr 17, 2015
- Review
- 120 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K964355 (1996). 42 ancestors in all, the oldest K881816 (1988). No later device cites it as a predicate yet.
- 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 deviceK143599 Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests…Chemtron Biotech, Inc. · 2015
View 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) | K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | Chemtron Biotech, Inc. | 2015 | — |
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 |
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? (2)
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 8…s (TCA) LFG Toxicology 91 21 CFR 862.3910 C. PREDICATE DEVICE 1 C-1. k061718 INNOVACON® Integrated E-Z Cup, submitter: INNOVACON Laboratories, Inc. C-2. k060896 OnSite CupKit™, submitter:… | 2006 |
| * | K060896 | Modification to Ontrak Testcup II and Onsite CupkitSummary page 8…1 C-1. k061718 INNOVACON® Integrated E-Z Cup, submitter: INNOVACON Laboratories, Inc. C-2. k060896 OnSite CupKit™, submitter: Varian, Inc. D. INDICATIONS FOR USE: Device Name: Chemtrue® Drug Screen Cup Tests… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 42 ancestors have a recall of any class.
- 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. 2015, 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® Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine 300, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants 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…
Read the full statement (475 words)
The Chemtrue® Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine 300, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants 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)
Buprenorphine BUP Buprenorphine 10
Tricyclic Antidepressants TCA Nortriptyline 1000
Amphetamine AMP d-Amphetamine 1000
Cocaine COC Benzoylecgonine 300
Methamphetamine MAMP d-Methamphetamine 1000
Morphine MOR Morphine 300
Phencyclidine PCP Phencyclidine 25
Marijuana THC 11-nor-A9-THC9 COOH 50
Benzodiazepines BZO Oxazepam 300
Barbiturates BAR Secobarbital/Pentobarbital 300
Ecstasy MDMA d,lI-Methylenedioxymethamphetamine 500
Methadone MTD Methadone 300
Oxycodone OXY Oxycodone 100
The Chemtrue® Drug Screen Cup Tests panel can consist of any combination of the above listed drug analytes. 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 and Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for these drugs in urine.
The Chemtrue Drug Screen Cup Tests with OPI 2000 are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants 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)
Buprenorphine BUP Buprenorphine 10
Tricyclic Antidepressants TCA Nortriptyline 1000
Amphetamine AMP d-Amphetamine 1000
Cocaine CcocC Benzoylecgonine 300
Methamphetamine MAMP d-Methamphetamine 1000
Opiates 2000 MOR Morphine 2000
Phencyclidine PCP Phencyclidine 25
Marijuana THC 11-nor-A9-THC9 COOH 50
Benzodiazepines BZO Oxazepam 300
Barbiturates BAR Secobarbital/Pentobarbital 300
Ecstasy MDMA d,l-Methylenedioxymethamphetamine 500
Methadone MTD Methadone 300
Oxycodone OXY Oxycodone 100
The Chemtrue Drug Screen Cup Tests with OPI 2000 panel can consist of any combination of the above listed drug analytes.
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 and Tricyclic Antidepressants. There are no uniformly recognized cutoff 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/K143599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143599: Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143599
Report an extraction error
Are you the manufacturer?
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