# K961256: Synchron Systems Valproic Acid (Vpa) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 15, 1996 after 44 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 K904226 (1990). 1 ancestor in all.
1 later device descends 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)
- K904226: 'Tdxflx Analyzer, Abbott Laboratories (1990) Summary page 1.

## Most influential descendants
- K031870: Synchron Systems Valproic Acid (V-PA) Reagent (2003), 0 descendants of its own

## Indications for use
The SYNCHRON Systems Valproic Acid reagent in conjunction with the SYNCHRON Drug Calibrator 1 is intended for use in the quantitative determination of valproic acid in human serum and plasma. This assay is designed for use with the family of SYNCHRON System analyzers which include the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

Source page: https://510kreport.com/device/K961256
Methodology: https://510kreport.com/methodology