510(k) · Cleared
ClearedAbuscreen (R) Online (TM) 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 1, 1991 after a 23-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 1, 1991
- Review
- 23 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK914509 Abuscreen (R) Online (TM) for BenzodiazepinesRoche Diagnostic Systems, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK983702 Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK043327 Online Dat Benzodiazepines PlusRoche Diagnostics Corp. · 2005
- Descendant · 3 generations on · 0 of its ownK221765 ONLINE DAT Benzodiazepines IIRoche Diagnostics · 2022
- Descendant · cites it directly · 0 of its ownK013882 Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110IOraSure Technologies, Inc. · 2002 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K983702Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999 · cites it directly2descendants
- K043327Online Dat Benzodiazepines PlusRoche Diagnostics Corp. · 2005 · 2 generations on1descendant
- K221765ONLINE DAT Benzodiazepines IIRoche Diagnostics · 2022 · 3 generations on0descendants
- K013882Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110IOraSure Technologies, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914509 | Abuscreen (R) Online (TM) for Benzodiazepines | Roche Diagnostic Systems, Inc. | 1991 | — |
| +1 | K983702 | Modification to Abuscreen Online for Benzoidiazepines | Roche Diagnostic Systems, Inc. | 1999 | — |
| +2 | K043327 | Online Dat Benzodiazepines Plus | Roche Diagnostics Corp. | 2005 | — |
| +3 | K221765 | ONLINE DAT Benzodiazepines II | Roche Diagnostics | 2022 | — |
| +1 | K013882 | Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110I | OraSure Technologies, Inc. | 2002 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2022 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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, K983702 (Roche Diagnostic Systems, Inc., 1999) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K914509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914509: Abuscreen (R) Online (TM) 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/K914509
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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