Bayer Valproic Acid Assay for ACS:180 and Advia Centaur Analyzers

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Bayer Valproic Acid Assay for the ACS:180 and Advia Centaur Analyzers

510(k) Number

K013959 ↗

FDA Product Code

DKB

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Bayer Diagnostics Corp. →

• What is the Bayer Valproic Acid Assay designed for?

  The Bayer Valproic Acid Assay is an in vitro diagnostic reagent kit designed specifically for quantitative measurement of valproic acid concentrations in patient samples. It is intended for use with the Bayer ACS:180 and Advia Centaur immunoassay analyzers to assist clinicians in monitoring therapeutic drug levels or detecting potential toxicity in clinical toxicology assessments.

• How is the Bayer Valproic Acid Assay supplied and prepared?

  The assay is supplied as a reagent kit for in vitro diagnostic use. It requires preparation and calibration directly on the designated ACS:180 or Advia Centaur analyzers before use. The kit includes all necessary components for performing the immunoassay, but setup and calibration must be completed according to the manufacturer’s instructions to ensure accurate results.

• Is the Bayer Valproic Acid Assay single-use or reusable?

  The Bayer Valproic Acid Assay is designed for single-use per manufacturer specifications. Each kit is intended for a limited number of tests as outlined in the accompanying documentation, and components should not be reused to maintain accuracy and prevent cross-contamination.

• Does the Bayer Valproic Acid Assay require sterilization?

  No, the assay does not require additional sterilization beyond standard laboratory handling procedures. As an in vitro diagnostic reagent kit, it is packaged and stored under controlled conditions to ensure sterility and reliability, but routine lab practices for cleanliness and contamination prevention should still be followed.

• What regulatory pathway does the Bayer Valproic Acid Assay follow?

  The assay holds an FDA 510(k) clearance under the Traditional pathway, with a Substantially Equivalent determination by the Clinical Toxicology Advisory Committee. This classification ensures compliance with FDA regulations for diagnostic accuracy and safety, specifically under device classification 862.3200 for calibrators and drug mixtures.