510(k) · Cleared
ClearedRoche Online TDM Lidocaine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · KLR Enzyme Immunoassay, Lidocaine
Cleared on Jan 12, 2004 as substantially equivalent to K954992 (Roche Diagnostic Systems, Inc., 1996) after a 167-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 12, 2004
- Review
- 167 days
- Class
- Class II
- Product code
- KLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954992 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK954992 Roche Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1996
- This deviceK032334 Roche Online TDM LidocaineRoche Diagnostics Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954992 | Roche Cobas Integra Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1996 | — |
| 0 (this device) | K032334 | Roche Online TDM Lidocaine | 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 KLR? 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 |
|---|---|---|---|
| * | K954992 | Roche Cobas Integra Reagent CassettesSummary page 1…d: July 28, 2003 2) Device name Roche ONLINE TDM Lidocaine 3) Predicate We claim substantial equivalence to the Roche COBAS INTEGRA Lidocaine device [K954992]. 4) Device The assay is a homogeneous immunoassay based on the principle of Description measuring changes in scatt… | 1996 |
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 no recall.
- 6 other devices also cite its predicate K954992.
How does its category compare?
All KLR devicesKLR Enzyme Immunoassay, Lidocaine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLR
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · KLR
Too few KLR 510(k)s in any year since 2007 to give a median.
Recalls per year · KLR
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLR
2in 2020
MAUDE reports naming product code KLR, 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 | 0 |
| 2009 | 1 | — | 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 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Roche ONLINE TDM Lidocaine assay is for the quantitative determination of lidocaine in human serum or plasma on automated clinical chemistry analyzers.
Lidocaine is an antiarrhythmic agent administered intravenously by either injection or continuous infusion. It is indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Lidocaine reagent kits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032334: Roche Online TDM Lidocaine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032334
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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