510(k) · Cleared
ClearedAbuscreen (R) Ontrak (TM) for Barbiturates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DKN Radioimmunoassay, Barbiturate
Cleared on Jul 28, 1988 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 28, 1988
- Review
- 91 days
- Class
- Class II
- Product code
- DKN
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK881816 Abuscreen (R) Ontrak (TM) for BarbituratesRoche Diagnostic Systems, Inc. · 1988
- Descendant · cites it directly · 6 of its ownK983174 Ontrak Teststik for Barbiturates, Ontrak Teststik for BenzodiazepinesRoche Diagnostic Systems, Inc. · 1998
- Descendant · 2 generations on · 5 of its ownK033902 Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004
- Descendant · 3 generations on · 4 of its ownK060896 Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006
- Descendant · 4 generations on · 2 of its ownK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- Descendant · 5 generations on · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K983174Ontrak Teststik for Barbiturates, Ontrak Teststik for BenzodiazepinesRoche Diagnostic Systems, Inc. · 1998 · cites it directly6descendants
- K033902Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004 · 2 generations on5descendants
- K060896Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006 · 3 generations on4descendants
- K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc. · 2016 · 4 generations on2descendants
- K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881816 | Abuscreen (R) Ontrak (TM) for Barbiturates | Roche Diagnostic Systems, Inc. | 1988 | — |
| +1 | K983174 | Ontrak Teststik for Barbiturates, Ontrak Teststik for Benzodiazepines | Roche Diagnostic Systems, Inc. | 1998 | — |
| +2 | K033902 | Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2004 | — |
| +3 | K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2006 | — |
| +4 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| +5 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K983174 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DKN devicesDKN Radioimmunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKN
FDA has decided no DKN device since 2007.
Median 510(k) review, days · DKN
Too few DKN 510(k)s in any year since 2007 to give a median.
Recalls per year · DKN
No recall names DKN since 2007.
Adverse event reports per year · DKN
No MAUDE report names DKN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K881816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881816: Abuscreen (R) Ontrak (TM) for Barbiturates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881816
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026