# K031870: Synchron Systems Valproic Acid (V-PA) Reagent

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jul 15, 2003 after 28 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: 2 generations back to K904226 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961256: Synchron Systems Valproic Acid (Vpa) Reagent, Beckman Instruments, Inc. (1996) Summary page 1.

## Indications for use
Valproic Acid (VPA) Reagent, in conjunction with the SYNCHRON* Systems Drug Calibrator 1 set, is intended for the quantitative determination of valproic acid concentration in human serum or plasma on SYNCHRON Systems. Valproic Acid is an anticonvulsant drug. It is indicated for the treatment of absence (petite mal), generalized tonic-clonic and myoclonic seizures. Valproic Acid therapy is monitored for suspected inadequate dose or toxicity. Valproic Acid Reagent is used to measure the valproic acid concentration by a particle enhanced turbidimetric inhibition immunoassay method.

Source page: https://510kreport.com/device/K031870
Methodology: https://510kreport.com/methodology