510(k) · Cleared
ClearedOnline Dat Benzodiazepines Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Feb 7, 2005 as substantially equivalent to K983702 (Roche Diagnostic Systems, Inc., 1999) after a 67-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Feb 7, 2005
- Review
- 67 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914509 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK914509 Abuscreen (R) Online (TM) for BenzodiazepinesRoche Diagnostic Systems, Inc. · 1991
- 1 generation backK983702 Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999
- This deviceK043327 Online Dat Benzodiazepines PlusRoche Diagnostics Corp. · 2005
- Descendant · cites it directly · 0 of its ownK221765 ONLINE DAT Benzodiazepines IIRoche Diagnostics · 2022
Most influential descendants
Showing 1 of 1 · See all- K221765ONLINE DAT Benzodiazepines IIRoche Diagnostics · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K043327 | Online Dat Benzodiazepines Plus | Roche Diagnostics Corp. | 2005 | — |
| +1 | K221765 | ONLINE DAT Benzodiazepines II | Roche Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K983702 | Modification to Abuscreen Online for BenzoidiazepinesSummary page 1…zyme immunoassay, Benzodiazepines 3) Predicate We claim substantial equivalence to the currently marketed Abuscreen device OnLine Benzodiazepines assay (K983702). Continued on next page… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221765 | ONLINE DAT Benzodiazepines II | 2022 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221765 (Roche Diagnostics, 2022) has gone furthest, with 0 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 | — |
What is it indicated for?
Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043327 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043327: Online Dat Benzodiazepines Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043327
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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