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ADVIA Centaur Anti-Thyroglobulin II (aTgII)

by Siemens Healthcare Diagnostics, Inc.

510(k) K250816

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250816↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250816 Date4 Dec 2025ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
JNL
Device Class
Class II
Regulation
21 CFR Part 866.5870
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ADVIA Centaur Anti-Thyroglobulin II (aTgII) is an immunochemical assay device designed for the quantitative detection of anti-thyroglobulin autoantibodies in human serum or plasma. It falls under the category of immunoassays, specifically measuring autoantibodies associated with thyroid disorders, such as Hashimoto’s thyroiditis or Graves’ disease, to aid in diagnostic evaluation.

This device is intended for use in clinical laboratories and is supplied as a reagent kit for automated immunoassay systems. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and IVDR conformity. The assay is intended for single-use per manufacturer specifications, with storage requirements and handling details outlined in the accompanying instructions for use.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical conditions is the ADVIA Centaur Anti-Thyroglobulin II (aTgII) assay primarily used to evaluate in patients?

    The ADVIA Centaur Anti-Thyroglobulin II (aTgII) assay is designed to quantitatively detect anti-thyroglobulin autoantibodies in human serum or plasma. These autoantibodies are associated with thyroid disorders such as Hashimoto’s thyroiditis and Graves’ disease, making the test useful for diagnostic evaluation in patients suspected of having these autoimmune conditions.

  • How is the ADVIA Centaur Anti-Thyroglobulin II (aTgII) assay supplied, and is it intended for single-use?

    The assay is supplied as a reagent kit specifically for automated immunoassay systems like the ADVIA Centaur platform. According to the manufacturer’s specifications, it is intended for single-use per test, meaning each reagent component is designed to be used once before disposal.

  • What type of regulatory approvals does the ADVIA Centaur Anti-Thyroglobulin II (aTgII) hold, and where is it filed?

    The device holds FDA 510(k) clearance and IVDR conformity, indicating it meets regulatory standards in the United States and aligns with the In Vitro Diagnostic Regulation in the EU. It was filed under the product code JNL and reviewed by the FDA’s Immunology (IM) Advisory Committee, with a decision date of December 4, 2025.

  • Can this assay be used with both serum and plasma samples, and what are the key storage requirements?

    Yes, the ADVIA Centaur Anti-Thyroglobulin II (aTgII) is intended for use with both human serum and plasma samples. Storage requirements and handling instructions are detailed in the accompanying instructions for use, though specifics like temperature ranges or expiration conditions must be referenced there for precise compliance.