# K032049: Roche Online TDM Valproic Acid

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 22, 2003 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 K930734 (1993). 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)
- K930734: Cedia Valporic Acid Assay, Microgenics Corp. (1993) Summary page 1.

## Indications for use
The Roche ONLINE TDM Valproic Acid assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of valproic acid in human serum or plasma on automated clinical chemistry analyzers. Valproic acid is primarily used in the treatment of petit mal seizures and other generalized and partial complex seizures.

Source page: https://510kreport.com/device/K032049
Methodology: https://510kreport.com/methodology