510(k) · Cleared
ClearedRoche Online TDM Valproic Acid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LEG Enzyme Immunoassay, Valproic Acid
Cleared on Aug 22, 2003 as substantially equivalent to K930734 (Microgenics Corp., 1993) after a 51-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 22, 2003
- Review
- 51 days
- Class
- Class II
- Product code
- LEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930734 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930734 Cedia Valporic Acid AssayMicrogenics Corp. · 1993
- This deviceK032049 Roche Online TDM Valproic AcidRoche Diagnostics Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930734 | Cedia Valporic Acid Assay | Microgenics Corp. | 1993 | — |
| 0 (this device) | K032049 | Roche Online TDM Valproic Acid | Roche Diagnostics Corp. | 2003 | — |
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 LEG? 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 |
|---|---|---|---|
| * | K930734 | Cedia Valporic Acid AssaySummary page 1…Date Prepared: June 27,2003 2) Device name Roche ONLINE TDM Valproic Acid 3) Predicate We claim substantial equivalence to the Roche Valproic I1 Assay [K930734]. device 4) Device The assay is a homogeneous immunoassay based on the principle of Description measuring changes i… | 1993 |
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.
- 1 other device also cites its predicate K930734.
How does its category compare?
All LEG devicesLEG Enzyme Immunoassay, Valproic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEG
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LEG
Too few LEG 510(k)s in any year since 2007 to give a median.
Recalls per year · LEG
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LEG
5in 2025
MAUDE reports naming product code LEG, 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 | — | 1 | 12 |
| 2008 | 0 | — | 0 | 38 |
| 2009 | 1 | — | 0 | 18 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 38 |
| 2012 | 0 | — | 0 | 29 |
| 2013 | 0 | — | 0 | 29 |
| 2014 | 0 | — | 0 | 20 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 1 | 24 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Roche ONLINE TDM Valproic Acid assay contains an in vitro diagnostic reagent system
indicated for the quantitative determination of valproic acid in human serum or plasma on
automated clinical chemistry analyzers. Valproic acid is primarily used in the treatment of petit
mal seizures and other generalized and partial complex seizures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032049: Roche Online TDM Valproic Acid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032049
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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