510(k) · Cleared
ClearedOntrak Teststik for Barbiturates, Ontrak Teststik for Benzodiazepines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Nov 18, 1998 as substantially equivalent to K881816 (Roche Diagnostic Systems, Inc., 1988) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1988. 6 later devices descend from it.
- Decided
- Nov 18, 1998
- Review
- 69 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881816 (1988). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK881816 Abuscreen (R) Ontrak (TM) for BarbituratesRoche Diagnostic Systems, Inc. · 1988
- This deviceK983174 Ontrak Teststik for Barbiturates, Ontrak Teststik for BenzodiazepinesRoche Diagnostic Systems, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK033902 Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK060896 Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- Descendant · 4 generations on · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
- Descendant · 5 generations on · 0 of its ownK252684 Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K033902Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004 · cites it directly5descendants
- K060896Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006 · 2 generations on4descendants
- K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc. · 2016 · 3 generations on2descendants
- K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc. · 2023 · 4 generations on1descendant
- K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881816 | Abuscreen (R) Ontrak (TM) for Barbiturates | Roche Diagnostic Systems, Inc. | 1988 | — |
| 0 (this device) | K983174 | Ontrak Teststik for Barbiturates, Ontrak Teststik for Benzodiazepines | Roche Diagnostic Systems, Inc. | 1998 | — |
| +1 | K033902 | Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2004 | — |
| +2 | K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2006 | — |
| +3 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| +4 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
| +5 | K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 JXM? 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 JXM device
- #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K881816 | Abuscreen (R) Ontrak (TM) for BarbituratesSummary page 3…, Inc. claims equivalence. Table 2 Product Name Predicate Product Date Predicate Name Predicate 510(k) Cleared Number ONTRAK TESTSTIK for|Abuscreen OnTrak for |[7/28/88 K881816/A Barbiturates Barbiturates ONTRAK TESTSTIK for|Abuscreen OnTrak for (4/05/91 K910590 Benzodiazepines Benzodiazepines IV. Descri… | 1988 |
| * | K910590 | Abuscreen Ontrak for BenzodiazepineSummary page 3…Predicate 510(k) Cleared Number ONTRAK TESTSTIK for|Abuscreen OnTrak for |[7/28/88 K881816/A Barbiturates Barbiturates ONTRAK TESTSTIK for|Abuscreen OnTrak for (4/05/91 K910590 Benzodiazepines Benzodiazepines IV. Description of the Device/Statement of Intended Use: The ONTRAK TESTSTIK Assays for Barbitu… | 1991 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033902 | Ontrak Testcup II and Onsite Cupkit | 2004 | 5 |
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?
How does its category compare?
All JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JXM
Too few JXM 510(k)s in any year since 2007 to give a median.
Recalls per year · JXM
79in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXM
6in 2025
MAUDE reports naming product code JXM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 79 | 5 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL.
Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose.
2. The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL.
Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.
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/K983174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983174: Ontrak Teststik for Barbiturates, Ontrak Teststik for Benzodiazepines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983174
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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