510(k) · Cleared
Recalled · 2010TDM N-Acetylprocainamide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LAN Enzyme Immunoassay, N-Acetylprocainamide
Cleared on Aug 16, 2006 as substantially equivalent to K951595 (Roche Diagnostic Systems, Inc., 1995) after a 149-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Aug 16, 2006
- Review
- 149 days
- Class
- Class II
- Product code
- LAN
- Recalls
- 1
- 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 deviceK060738 TDM N-AcetylprocainamideRoche Diagnostics Corp. · 2006
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) | K060738 | TDM N-Acetylprocainamide | Roche Diagnostics Corp. | 2006 | — |
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 LAN? 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…marketed COBAS 3) Predicate We claim substantial equivalence to the currently INTEGRA N-acetylprocainamide (K95 1595). device Continued on next page… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 5, 2010 | Not classified | Z-2386-2010 | Error in labeling | The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011. |
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 LAN devicesLAN Enzyme Immunoassay, N-Acetylprocainamide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAN
FDA has decided no LAN device since 2007.
Median 510(k) review, days · LAN
Too few LAN 510(k)s in any year since 2007 to give a median.
Recalls per year · LAN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LAN
No MAUDE report names LAN since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 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 | — | 0 | — |
What is it indicated for?
The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of N-acetylprocainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained from this device are used in the diagnosis and treatement of N-acetylprocainamide overdose and in monitoring the levels of N-acetylprocainamide to help ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060738: TDM N-Acetylprocainamide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060738
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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