# K982880: Dimension (R) Valproic (Valp) Acid Method

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 25, 1998 after 11 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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 AxSYM® Valproic Acid Assay: named in the summary without a submission number

## Most influential descendants
- K061655: Dimension Vista Flex Reagent Cartridges (2006), 1 descendant of its own
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own

## Indications for use
The VALP method for the Dimension® RxL clinical chemistry system is a device used to measure valproic acid, an anti-convulsant drug, in serum or plasma. VALP test results may be 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/K982880
Methodology: https://510kreport.com/methodology