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510(k) Data Aggregation

    K Number
    K250816

    Validate with FDA (Live)

    Device Name
    ADVIA Centaur Anti-Thyroglobulin II (aTgII)
    Manufacturer
    Siemens Healthcare Diagnostics, Inc.
    Date Cleared
    2025-12-04

    (261 days)

    Product Code
    JNL,JJX,JZO
    Regulation Number
    866.5870
    Type
    Traditional
    Panel
    Immunology
    Age Range
    22 - 120
    Reference & Predicate Devices
    K112933
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ADVIA Centaur Anti-Thyroglobulin II (aTgII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroglobulin in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system.

    Anti-thyroglobulin (aTg) measurements are used, in conjunction with clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis and Graves' disease.

    Device Description
    ComponentVolumeIngredients
    ADVIA Centaur aTgII Primary Reagent ReadyPack (included in assay kit)
    ADVIA Centaur aTgII Lite Reagent10.0 mL/packHuman thyroglobulin labeled with acridinium ester (~1.2 µg/mL); buffered saline; bovine gamma globulin;
    ADVIA Centaur aTgII Solid Phase Reagent20.0 mL/packBiotinylated human thyroglobulin bound to streptavidin-coated paramagnetic particles (~0.6 mg/mL); buffered saline; bovine gamma globulin; BSA; sodium azide (< 0.1%); preservative
    ADVIA Centaur aTgII Ancillary Reagent ReadyPack (included in assay kit)
    ADVIA Centaur aTgII Ancillary Reagent17.5 mL/packGoat serum; mouse serum; sodium azide (< 0.1%); preservative
    ADVIA Centaur aTgII Calibrator (included in assay kit)
    ADVIA Centaur aTgII Low and High Calibrators1.0 mL/vial LyophilizedAfter reconstitution, low or high levels of monoclonal mouse anti-human thyroglobulin; goat serum; mouse serum; sodium azide (< 0.1%); preservative
    AI/ML Overview

    N/A

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