# K013959: Bayer Valproic Acid Assay for the Acs:180 and Advia Centaur Analyzers

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Jan 29, 2002 after 60 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 K904226 (1990). 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)
- K904226: 'Tdxflx Analyzer, Abbott Laboratories (1990) Summary page 1.

## Indications for use
The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of valproic acid in human serum and plasma for use on the automated analyzers marketed by Bayer Corporation. Valproic acid (2-propylpentanoic acid) is an anticonvulsant that is used alone or in combination with other anticonvulsant drugs to control seizures. Monitoring of valproic acid ensures that there is adequate drug in the blood stream without being at toxic levels. The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are used as an aid to monitor patients' valproic acid level.

Source page: https://510kreport.com/device/K013959
Methodology: https://510kreport.com/methodology