510(k) · Cleared
ClearedModification to Abuscreen Online for Benzoidiazepines
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 Feb 11, 1999 as substantially equivalent to K914509 (Roche Diagnostic Systems, Inc., 1991) after a 113-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Feb 11, 1999
- Review
- 113 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914509 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914509 Abuscreen (R) Online (TM) for BenzodiazepinesRoche Diagnostic Systems, Inc. · 1991
- This deviceK983702 Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK043327 Online Dat Benzodiazepines PlusRoche Diagnostics Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK221765 ONLINE DAT Benzodiazepines IIRoche Diagnostics · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914509 | Abuscreen (R) Online (TM) for Benzodiazepines | Roche Diagnostic Systems, Inc. | 1991 | — |
| 0 (this device) | K983702 | Modification to Abuscreen Online for Benzoidiazepines | Roche Diagnostic Systems, Inc. | 1999 | — |
| +1 | K043327 | Online Dat Benzodiazepines Plus | Roche Diagnostics Corp. | 2005 | — |
| +2 | K221765 | ONLINE DAT Benzodiazepines II | Roche Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K914509 | Abuscreen (R) Online (TM) for BenzodiazepinesSummary page 2…gnostic Systems, Inc. claims equivalence. Table 2 Product Name Predicate Product 510(k) Number and Date Name Predicate Cleared Abuscreen ONLINE for Abuscreen ONLINE for K914509 11/1/91 Benzodiazepines Benzodiazepines 15 Roche Diagnostic Systems, Inc. Abuscreen ONLINE® Benzodiazepines Som… | 1991 |
| † | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043327 | Online Dat Benzodiazepines Plus | 2005 | 1 |
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?
Abuscreen ONLINE Benzodiazepines is an in vifra diagnostic test for the
qualitative and semiquantitative detection of benzodiazepines in human urine on
the Hitachi 917 analyzer at cutoff concentrations of 100 ng/mL, 200 ng/mL, and
300 ng/mL. Semiquantitative test results may be obtained that permit laboratories
to assess assay performance as part of a quality control program. Measurements
obtained by this device are used in the diagnosis of benzodiazepine use or abuse.
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/K983702 · printed Nov 3, 2026
Cite this page
510(k) Report. “K983702: Modification to Abuscreen Online for Benzoidiazepines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K983702
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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