ADVIA Centaur Intact Parathyroid Hormone (PTH) 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 17 Oct 2026.

Trade Name

ADVIA Centaur® PTH

Generic Name

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Device Name

IVDR_67_TTN_DUB-C_b_kit_pth

Model / Ref / Catalog

10699155, IVDR_67_TTN_DUB-C_B_KIT_PTH

Primary DI / UDI-DI

00630414592343

Basic UDI-DI

0405686901625VQ

Unit of Use DI

00630414017242

510(k) Number

K163658 ↗

FDA Product Code

CEW

EMDN Code

W0102060312 Parathyroid hormone intact

GMDN Term

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

Device Class

Class B EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 862.1545

EU market of registration

Germany

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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• What clinical setting or laboratory type is the ADVIA Centaur Intact PTH Assay intended for use in?

  The ADVIA Centaur Intact PTH Assay is designed specifically for clinical chemistry laboratories. It is intended for quantitative measurement of intact parathyroid hormone (PTH) in human serum and plasma, enabling precise clinical assessment of PTH levels in a controlled lab environment.

• How is the ADVIA Centaur Intact PTH Assay supplied, and is it single-use?

  The assay is supplied as a reagent kit that requires preparation and calibration according to the manufacturer’s instructions. Unlike single-use devices, this is not a disposable—it is intended for repeated use within a laboratory setting, provided proper handling and storage guidelines are followed.

• What detection method does the ADVIA Centaur Intact PTH Assay use, and why is it significant?

  The assay employs a chemiluminescent detection method using a high-quantum-yield Zwitterionic Acridinium Ester (ZAE) label. This technology enhances sensitivity and reduces non-specific binding, improving the accuracy and reliability of PTH measurements in clinical samples.

• Are there any special storage requirements for the ADVIA Centaur Intact PTH Assay reagents?

  Yes, the reagents require storage at controlled temperatures to maintain stability. The manufacturer’s instructions must be followed to ensure optimal performance, as improper storage could compromise assay accuracy or reagent efficacy.

• What regulatory pathways does the ADVIA Centaur Intact PTH Assay follow, and how does this affect its use?

  The assay is cleared under the FDA’s 510(k) pathway (K163658) and complies with the In Vitro Diagnostic Regulation (IVDR). This means it has undergone evaluation for safety and performance, ensuring it meets regulatory standards for clinical use in the U.S. and EU markets. No MRI safety restrictions apply, as it is not a medical imaging device.