ADVIA Centaur CEA Assay

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

Trade Name

ADVIA Centaur® CEA

Generic Name

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Device Name

IVDR_67_TTN_DUB-C_c_kit_cea

Model / Ref / Catalog

10309977, IVDR_67_TTN_DUB-C_C_KIT_CEA, 110761

Primary DI / UDI-DI

00630414177304

Basic UDI-DI

0405686901803VQ

510(k) Number

K200215 ↗

FDA Product Code

DHX

EMDN Code

W0102030112 Carcinoembryonic antigen

GMDN Term

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

Device Class

Class C EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 866.6010

EU market of registration

Germany

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• What clinical scenarios is the ADVIA Centaur CEA Assay primarily used to support in patient monitoring?

  The ADVIA Centaur CEA Assay is designed for quantitative measurement of carcinoembryonic antigen (CEA) in human serum or plasma, aiding in the monitoring of cancer patients—particularly those with colorectal, pancreatic, or gastric malignancies. It helps clinicians track disease progression, response to treatment, or recurrence by assessing CEA levels over time.

• How is the ADVIA Centaur CEA Assay supplied, and is it intended for single-use or reuse?

  The assay is supplied as a reagent kit exclusively for use on the ADVIA Centaur immunoassay system. It is intended for single-use only, with no sterilization required beyond the manufacturer-provided packaging. This ensures consistency and reduces contamination risks in laboratory settings.

• What type of sample can be tested with this assay, and does it require special handling?

  The assay is validated for use with human serum or plasma samples. No additional sterilization or special handling is required beyond adhering to standard laboratory protocols for sample collection and storage, as outlined in the manufacturer’s instructions.

• Is this assay compatible with any specific laboratory equipment, and how is it regulated?

  The ADVIA Centaur CEA Assay is exclusively designed for use on the ADVIA Centaur immunoassay system, a fully automated chemiluminescent platform. Regulatory-wise, it holds FDA 510(k) clearance (K200215) and complies with the EU’s In Vitro Diagnostic Regulation (IVDR), ensuring its suitability for clinical use in both markets.

• Are there different sizes or models of this assay, or is it a single standardized test?

  The ADVIA Centaur CEA Assay is a single standardized test for measuring CEA levels, supplied as a reagent kit. While the system supports multiple assays (as indicated by the product codes), this specific assay does not vary in size or model—it is a uniform reagent kit for the ADVIA Centaur platform.