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510(k) Data Aggregation

    K Number
    K080167
    Device Name
    ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2008-08-08

    (198 days)

    Product Code
    CEC
    Regulation Number
    862.1695
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k961510
    Why did this record match?
    Device Name :

    ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS

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

    The ADVIA Centaur FT4 Immunoassay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in serum or plasma (heparinized or EDTA) using the ADVIA Centaur and ADVIA Centaur XP Systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid diseases.

    Device Description

    The ADVIA Centaur FT4 assay is a competitive immunoassay using direct, chemiluminescent technology. Free thyroxine in the patient sample competes with acridinium ester-labeled T4 in the Lite Reagent for a limited amount of biotinylated polyclonal rabbit anti-T4 antibody that is bound to avidin that is covalently coupled to paramagnetic particles in the Solid Phase. There is an inverse relationship between the concentration of free thyroxine in the sample and relative light units (chemiluminescence).

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the ADVIA Centaur FT4 Immunoassay, based on the provided 510(k) summary:

    Acceptance Criteria and Device Performance

    The provided document describes the performance characteristics without explicitly stating pre-defined "acceptance criteria" but rather demonstrates substantial equivalence to a predicate device. For the purpose of this analysis, we can infer acceptance criteria as demonstrating comparable performance to the predicate device within reasonable experimental variation.

    Table of Acceptance Criteria (Inferred) and Reported Device Performance

    Performance CharacteristicInferred Acceptance Criteria (Comparable to Predicate Device)ADVIA Centaur FT4 Performance (New Device)Predicate Device (ACS:180 FrT4) Performance
    Imprecision (Total CV%)Comparable total CV% across various FT4 levels0.37 ng/dL: 11.2%0.58 ng/dL: 4.86%
    0.71 ng/dL: 4.85%--
    1.31 ng/dL: 3.98%1.42 ng/dL: 1.92%
    3.35 ng/dL: 4.07%3.37 ng/dL: 3.55%
    5.32 ng/dL: 4.02%--
    9.68 ng/dL: 6.53%--
    (Study #2) 0.72 ng/dL: 4.16%
    (Study #2) 1.47 ng/dL: 4.58%
    (Study #2) 3.01 ng/dL: 4.44%
    Specificity (% Cross Reactivity)Very low cross-reactivity (
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