# K973581: Ace Valproic Acid Reagent, Aed Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Nov 12, 1997 after 51 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 K961988 (1996). 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)
- K961988: Valproic Acid Eia Test, Diagnostic Reagents, Inc. (1996) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K973581
Methodology: https://510kreport.com/methodology