# K981403: Immage Immunochemistry System Valproic Acid (Vpa) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 8, 1998 after 21 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- 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 IMMAGE Immunochemistry System Valproic Acid (VPA) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.

Source page: https://510kreport.com/device/K981403
Methodology: https://510kreport.com/methodology