510(k) · Cleared
ClearedQMS / Multigent Valproic Acid Reagent, Part #396075
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seradyn · LEG Enzyme Immunoassay, Valproic Acid
Cleared on Apr 28, 2003 as substantially equivalent to K941615 (Abbott Laboratories, 1994) after an 81-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 28, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- LEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941615 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941615 Axsym Valproic AcidAbbott Laboratories · 1994
- This deviceK030405 QMS / Multigent Valproic Acid Reagent, Part #396075Seradyn · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941615 | Axsym Valproic Acid | Abbott Laboratories | 1994 | — |
| 0 (this device) | K030405 | QMS / Multigent Valproic Acid Reagent, Part #396075 | Seradyn | 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 |
|---|---|---|---|
| * | K941615 | Axsym Valproic AcidSummary page 1…claimed: Seradyn QMSTM1 MULTIGENTTMValproic Acid on the Abbott AEROSET@System is substantially equivalent to the Abbott AxSYM@Valproic Acid cleared under K94 1615. 5. DescriDtion of Device: The Seradyn QMSTM / MULTIGENTTMValproic Acid Assay is a homogeneous Particle Enhance… | 1994 |
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.
- 2 other devices also cite its predicate K941615.
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 SERADYN QMSTM/MULTIGENTmVALPROICACID assay is used for the quantitation of valproic acid in human serum or plasma on the Abbott AEROSET~System. Valproic acid (VPA; 2-propylpentanoic acid; Depakene@)is a broad-spectrum anticonvulsant drug used solely or in combination with other anticonvulsant drugs for the treatment of absence seizures. It also has demonstrated effectiveness in the management of generalized tonic-clonic and myoclonic seizures, as…
Read the full statement (178 words)
The SERADYN QMSTM/MULTIGENTmVALPROICACID assay is used for the quantitation of valproic acid in human serum or plasma on the Abbott AEROSET~System.
Valproic acid (VPA; 2-propylpentanoic acid; Depakene@)is a broad-spectrum anticonvulsant drug used solely or in combination with other anticonvulsant drugs for the treatment of absence seizures. It also has demonstrated effectiveness in the management of generalized tonic-clonic and myoclonic seizures, as well as atypical absence, simple and complex partial and mixed grand mal and petit ma seizures. The capability of treating many types of seizures with a single anticonvulsant has resulted in the wide-spread use of valproic acid, particularly n - children in whom tonic-clonic and myoclonic seizures are most prevalent. Valproic acid has proven effective in the treatment of many patients otherwise refractory to other anticonvulsant treatments. Most patients receiving valproic acid do not develop a tolerance to its anticonvulsant effects.
Monitoring serum valproic acid levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmhLtoiic dosage levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030405: QMS / Multigent Valproic Acid Reagent, Part #396075.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030405
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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