Advia Digoxin Assay for Integrated Module System

No FDA recalls on record, checked 6 Oct 2026.

Full name

Bayer Advia Digoxin Assay for the Integrated Module System

510(k) Number

K033007 ↗

FDA Product Code

KXT

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Bayer Diagnostics Corp. →

• What clinical area does the Bayer Advia Digoxin Assay support, and how does it help in patient care?

  The Bayer Advia Digoxin Assay is designed for clinical toxicology assessments, specifically to quantitatively measure digoxin levels in human serum. Digoxin is a cardioactive medication used in cardiac therapy, so precise measurements help clinicians diagnose digoxin overdose or monitor therapeutic levels, ensuring safe and effective treatment for patients.

• Is this assay compatible with any specific laboratory system, and how is it supplied?

  Yes, the Bayer Advia Digoxin Assay is intended exclusively for use with the Integrated Module System—it is not a standalone device. It is supplied as a diagnostic reagent kit, meaning it includes all necessary components for performing the enzyme immunoassay in a clinical lab setting.

• Are there multiple versions or sizes of this assay, and how would I identify the correct one for my lab?

  The data lists multiple registration numbers (e.g., 3004192065, 3010939897, etc.), which may correspond to different lot codes or configurations for the assay. While exact sizes or models aren’t specified, these identifiers help track compliance and inventory. Confirming the correct version would require cross-referencing with Bayer Diagnostics’ documentation or support team, as the assay is designed for the Integrated Module System without size variations.

• How is the sterility and single-use/reuse status of this assay determined, and what storage requirements apply?

  The provided data does not explicitly state whether the assay is sterile or single-use/reusable, so those details would need to be verified directly from Bayer Diagnostics’ labeling or instructions for use. For storage, enzyme immunoassay reagents like this typically require refrigeration (2–8°C) and protection from light, though exact conditions should be confirmed with the manufacturer to maintain assay integrity.

• What regulatory pathway was followed for this assay’s clearance, and how does that affect its use in clinical toxicology?

  The Bayer Advia Digoxin Assay received FDA 510(k) clearance (K033007) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. This clearance was reviewed by the Clinical Chemistry Devices Panel (CH) and classified under product code KXT, confirming its role in clinical toxicology. The approval ensures it meets FDA standards for accuracy and safety in measuring digoxin levels, supporting reliable patient monitoring.