510(k) · Cleared
ClearedAce Valproic Acid Reagent, Aed Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · LEG Enzyme Immunoassay, Valproic Acid
Cleared on Nov 12, 1997 as substantially equivalent to K961988 (Diagnostic Reagents, Inc., 1996) after a 51-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 12, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- LEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961988 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961988 Valproic Acid Eia TestDiagnostic Reagents, Inc. · 1996
- This deviceK973581 Ace Valproic Acid Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961988 | Valproic Acid Eia Test | Diagnostic Reagents, Inc. | 1996 | — |
| 0 (this device) | K973581 | Ace Valproic Acid Reagent, Aed Calibrators | Schiapparelli Biosystems, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K961988 | Valproic Acid Eia TestSummary page 1…: Enzyme immunoassay for valproic acid Classification Name: Valproic Acid test Predicate Device: Diagnostic Reagents, Inc. (DRI) - Valproic Acid Reagent [510(k) Number K961988] Device Description The ACE® Valproic Acid Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate… | 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.
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?
ACE® Valproic Acid Reagent is intended for the quantitative determination of
valproic acid in serum using the ACE® clinical chemistry analyzer.
Valproic acid (VPA, 2-propylpentanoic acid; Depakene®) is an anticonvulsant used chiefly for the treatment of primary and secondary generalized seizures,
but is also effective against absence seizures. Valproic acid is particularly
effective in myoclonus, and is the drug of choice in photosensitive epilepsy.
Valproic acid can be used concurrently with other anticonvulsants or alone.
Valproic acid may also be useful in the treatment of affective disorders, in
particular, lithium-insensitive bipolar disorders.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973581 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973581: Ace Valproic Acid Reagent, Aed Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973581
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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