510(k) · Cleared
ClearedArchitect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories, Inc. · LEG Enzyme Immunoassay, Valproic Acid
Cleared on Aug 6, 2009 as substantially equivalent to K941615 (Abbott Laboratories, 1994) after a 175-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 6, 2009
- Review
- 175 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 deviceK090358 Architect Ivalproic Acid Reagents and Architect Ivalproic Acid…Abbott Laboratories, Inc. · 2009
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) | K090358 | Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators… | Abbott Laboratories, Inc. | 2009 | — |
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 2…Page 1 of 3 510(k) Submission Legally marketed device to which equivalency is claimed: AxSYM Valproic Acid (K941615) Intended Use of Device: The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immu… | 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. 2009, this device’s year, is highlighted.
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 ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.
The ARCHITECT iValproic Acid Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of valproic acid in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090358: Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090358
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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