510(k) · Cleared
ClearedRoche Online TDM Quinidine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LBZ Enzyme Immunoassay, Quinidine
Cleared on Jan 12, 2004 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) after a 167-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 12, 2004
- Review
- 167 days
- Class
- Class II
- Product code
- LBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951595 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951595 Roche Cobas Integra Analyzer, Reagent CassettesRoche Diagnostic Systems, Inc. · 1995 · Recalled
- This deviceK032332 Roche Online TDM QuinidineRoche Diagnostics Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951595 | Roche Cobas Integra Analyzer, Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1995 | 7 |
| 0 (this device) | K032332 | Roche Online TDM Quinidine | Roche Diagnostics Corp. | 2004 | — |
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 LBZ? 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? (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 |
|---|---|---|---|
| * | K951595 | Roche Cobas Integra Analyzer, Reagent CassettesSummary page 1…d: July 28, 2003 2) Device name Roche ONLINE TDM Quinidine 3) Predicate We claim substantial equivalence to the Roche COBAS INTEGRA Quinidine device [K951595]. 4) Device The assay is a homogeneous immunoassay based on the principle of Description measuring changes in scatt… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 31 other devices also cite its predicate K951595.
How does its category compare?
All LBZ devicesLBZ Enzyme Immunoassay, Quinidine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBZ
FDA has decided no LBZ device since 2007.
Median 510(k) review, days · LBZ
Too few LBZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LBZ
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBZ
3in 2007
MAUDE reports naming product code LBZ, 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 | 3 |
| 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 | — | 2 | — |
What is it indicated for?
The Roche ONLINE TDM Quinidine assay is for the quantitative determination of quinidine in
human serum or plasma on automated clinical chemistry analyzers. Quinidine is used for the
prevention and treatment of ventricular arrhthmias, junctional (nodal) arrhythmias, and
supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic
serum levels is dependent on the drug formulation, patient age, and individual variability in
absorption and metabolism. The proposed labeling indicates the Roche/Hitachi 911, 912, 917,
and Modular P analyzers can be used with the Roche ONLINE Quinidine reagent kits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032332 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032332: Roche Online TDM Quinidine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032332
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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