# K972132: Sigma Diagnostics Valproic Acid Fpia Reagent Set, Sigma Diagnostics Valproic Acid Fpia Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Jul 30, 1997 after 54 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott Laboratories Valproic Acid TDx Reagent Set: named in the summary without a submission number

## Indications for use
Sigma Diagnostics Valproic Acid FPIA Reagent Set is intended to measure valproic acid, an anticonvulsant drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

Source page: https://510kreport.com/device/K972132
Methodology: https://510kreport.com/methodology