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    K Number
    K191533
    Device Name
    ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2019-08-28

    (79 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K091867,K151986
    Why did this record match?
    Device Name :

    ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ADVIA Centaur® Testosterone II (TSTII)

    The ADVIA Centaur® Testosterone II (TSTI) assav is for in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system.

    Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

    ADVIA Centaur® SHBG

    The ADVIA Centaur® SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur XP system.

    The ADVIA Centaur SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.

    Device Description

    The re-standardized ADVIA Centaur® Testosterone II (TSTII) and the ADVIA Centaur® SHBG are in vitro diagnostic immunoassays for use on the ADVIA Centaur® XP system. The ADVIA Centaur® Testosterone II (TSTII) assay quantitatively determines total testosterone in human serum and plasma. The ADVIA Centaur® SHBG assay quantitatively determines sex hormone-binding globulin (SHBG) in human serum and plasma. The submission includes details on the ingredients of the reagents for both assays.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the ADVIA Centaur® Testosterone II (TSTII) and ADVIA Centaur® SHBG based on the provided text, formatted as requested:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance CharacteristicAcceptance Criteria (ADVIA Centaur® Testosterone II (TSTII))Reported Device Performance (ADVIA Centaur® Testosterone II (TSTII))Acceptance Criteria (ADVIA Centaur® SHBG)Reported Device Performance (ADVIA Centaur® SHBG)
    Detection Limits
    Limit of Blank (LoB)(Implicitly good performance relative to predicate)2.50 ng/dL(Not explicitly provided in this document)(Previously established, see K151986 & K091867)
    Limit of Detection (LoD)(Implicitly good performance relative to predicate)5.00 ng/dL (95% probability)(Not explicitly provided in this document)(Previously established, see K151986 & K091867)
    Limit of Quantitation (LoQ)(Total CV of 20%)7.00 ng/dL (at 20% CV)(Not explicitly provided in this document)(Previously established, see K151986 & K091867)
    Precision(Implicitly good performance relative to predicate)See table below for detailed CVs across various samples and concentrations. Generally, Within-Run CVs are lower than Within-Lab CVs.(Not explicitly provided in this document)(Previously established, see K151986 & K091867)
    LinearityBias from linear fit estimate
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