510(k) · Cleared
ClearedCedia Valporic Acid Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corp. · LEG Enzyme Immunoassay, Valproic Acid
Cleared on Sep 21, 1993 after a 222-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Sep 21, 1993
- Review
- 222 days
- Class
- Class II
- Product code
- LEG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK930734 Cedia Valporic Acid AssayMicrogenics Corp. · 1993
- Descendant · cites it directly · 1 of its ownK961659 Cedia Core TDM Multi-CalBoehringer Mannheim Corp. · 1996
- Descendant · 2 generations on · 0 of its ownK120936 Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS…Microgenics Corporation · 2012
- Descendant · cites it directly · 0 of its ownK032049 Roche Online TDM Valproic AcidRoche Diagnostics Corp. · 2003
Most influential descendants
Showing 3 of 3 · See all- K961659Cedia Core TDM Multi-CalBoehringer Mannheim Corp. · 1996 · cites it directly1descendant
- K120936Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent…Microgenics Corporation · 2012 · 2 generations on0descendants
- K032049Roche Online TDM Valproic AcidRoche Diagnostics Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930734 | Cedia Valporic Acid Assay | Microgenics Corp. | 1993 | — |
| +1 | K961659 | Cedia Core TDM Multi-Cal | Boehringer Mannheim Corp. | 1996 | — |
| +2 | K120936 | Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS… | Microgenics Corporation | 2012 | — |
| +1 | K032049 | Roche Online TDM Valproic Acid | Roche Diagnostics Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K961659 (Boehringer Mannheim Corp., 1996) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K930734 · printed Nov 5, 2026
Cite this page
510(k) Report. “K930734: Cedia Valporic Acid Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K930734
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026