BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ADVIA Centaur Anti-Thyroid Peroxidase II

    K Number: K250250 · Decision Oct 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    152
    Review Days
    262

    Basic Information

    Device Name
    ADVIA Centaur Anti-Thyroid Peroxidase II
    K Number
    K250250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    January 28, 2025
    Decision Date
    October 17, 2025
    Product Code
    JZO
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JZO System, Test, Thyroid Autoantibody

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JZO), ordered by most recent decision date.

    Access TPO Antibody

    FDA 510(k)
    FDA Class 2 ·Immunology

    Access Thyroglobulin Antibody II

    FDA 510(k)
    FDA Class 2 ·Immunology

    Elecsys Anti-Tg

    FDA 510(k)
    FDA Class 2 ·Immunology

    Elecsys Anti-TSHR

    FDA 510(k)
    FDA Class 2 ·Immunology

    EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Siemens Healthcare Diagnostics, Inc.

    K Number Device Name
    K251998 Atellica CH Diazo Total Bilirubin (D_TBil)
    K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)
    K251630 Atellica IM Total PSA II (tPSAII)
    K250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)
    K242981 Atellica IM Thyroglobulin (Tg)
    K242685 Atellica® CH Creatinine_3 (Crea3)
    K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
    K241165 Atellica® IM High-Sensitivity Troponin I (TnIH)
    K233050 ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
    K233242 Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
    Search all 152 clearances from Siemens Healthcare Diagnostics, Inc. →