# K090358: Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories, Inc.
- Decided: Aug 6, 2009 after 175 days
- Product code: LEG (Enzyme Immunoassay, Valproic Acid)
- Device class: 2
- Regulation: 21 CFR 862.3645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941615 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941615: Axsym Valproic Acid, Abbott Laboratories (1994) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K090358
Methodology: https://510kreport.com/methodology