# K030405: QMS / Multigent Valproic Acid Reagent, Part #396075

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn
- Decided: Apr 28, 2003 after 81 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 1.

## Indications for use
The SERADYN QMSTM/MULTIGENTmVALPROICACID assay is used for the quantitation of valproic acid in human serum or plasma on the Abbott AEROSET~System. Valproic acid (VPA; 2-propylpentanoic acid; Depakene@)is a broad-spectrum anticonvulsant drug used solely or in combination with other anticonvulsant drugs for the treatment of absence seizures. It also has demonstrated effectiveness in the management of generalized tonic-clonic and myoclonic seizures, as well as atypical absence, simple and complex partial and mixed grand mal and petit ma seizures. The capability of treating many types of seizures with a single anticonvulsant has resulted in the wide-spread use of valproic acid, particularly n - children in whom tonic-clonic and myoclonic seizures are most prevalent. Valproic acid has proven effective in the treatment of many patients otherwise refractory to other anticonvulsant treatments. Most patients receiving valproic acid do not develop a tolerance to its anticonvulsant effects. Monitoring serum valproic acid levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmhLtoiic dosage levels.

Source page: https://510kreport.com/device/K030405
Methodology: https://510kreport.com/methodology