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510(k) Data Aggregation

    K Number
    K033036
    Device Name
    BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2004-02-03

    (127 days)

    Product Code
    MOI,JIT
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    k963926
    Why did this record match?
    Reference Devices :

    K963926

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

    The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.

    Device Description

    The Access BR Monitor reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of CA 15-3 antigen in human serum and plasma.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter Access BR Monitor, based on the provided document:

    Acceptance Criteria and Device Performance

    Acceptance Criteria CategorySpecific Criteria/MetricReported Device Performance/Result
    Imprecision (Analytical)Within-run imprecision (CV)Ranged from 1.4% CV to 2.2% CV for concentrations from ~15 to 662 U/mL.
    Between-run imprecision (CV)Ranged from 1.6% CV to 4.1% CV.
    Total imprecision (CV)Ranged from 2.1% CV to 4.6% CV.
    Analytical SensitivityLowest detectable level of CA 15-3 antigen
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