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    K Number
    K051456
    Device Name
    SENTINEL CERULOPLASMIN
    Manufacturer
    SENTINEL CH. SRL
    Date Cleared
    2005-10-21

    (141 days)

    Product Code
    JFR
    Regulation Number
    866.5210
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K921661
    Why did this record match?
    Product Code :

    JFR

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

    The Sentinel Ceruloplasmin assay is used for the quantitation of ceruloplasmin (copper-transporting serum protein) levels in human serum or plasma. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorder.

    Device Description

    Sentinel Ceruloplasmin is an in vitro diagnostic assay for the quantitative determination of ceruloplasmin in serum or plasma. The Sentinel Ceruloplasmin assay is a two-reagent format based on the immunological reaction between anti-ceruloplasmin antibonds specific for ceruloplasmin. The turbidity of the immunocomplex is proportional to the concentration of the analyte in the sample.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Sentinel Ceruloplasmin assay, broken down according to your requested criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (Implied by Predicate)Reported Device Performance (Sentinel Ceruloplasmin)
    Method Correlation (Slope)Close to 1.0 (indicating good agreement)1.0256
    Method Correlation (Y-intercept)Close to 0 (indicating no systematic bias)-1.0205 mg/dL
    Total %CV (Precision) - Level 1Comparable to predicate (not explicitly stated, but generally
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