LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250250
    Device Name
    ADVIA Centaur Anti-Thyroid Peroxidase II
    Manufacturer
    Siemens Healthcare Diagnostics, Inc.
    Date Cleared
    2025-10-17

    (262 days)

    Product Code
    JZO,JIT,JJX
    Regulation Number
    866.5870
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K052407
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system.

    Anti-thyroid peroxidase (aTPO) measurements are used, in conjunction with a clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis and/or Graves' disease.

    Device Description

    The ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) consists of:

    • aTPOII ReadyPack® primary reagent pack (Lite Reagent, Solid Phase)
    • aTPOII CAL
      Devices sold separately and included in the ADVIA Centaur® Anti-Thyroid Peroxidase II (aTPOII) are:
    • ADVIA Centaur aTPOII MCM (MCM 1, MCM 2–4)
    • ADVIA Centaur aTPOII QC
    • ADVIA Centaur aTPOII DIL ReadyPack ancillary reagent pack
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1