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510(k) Data Aggregation

    K Number
    K073489
    Device Name
    OLYMPUS IGA REAGENT
    Manufacturer
    OLYMPUS AMERICA INC.
    Date Cleared
    2008-02-11

    (61 days)

    Product Code
    CFN
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K951055
    Why did this record match?
    Device Name :

    OLYMPUS IGA REAGENT

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

    System reagent for the quantitative determination of IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.
    For in vitro diagnostic use.

    Device Description

    In this Olympus procedure:
    When a sample is mixed with R1 buffer and R2 antiserum solution, human IgA reacts specifically with anti-human IgA antibodies to yield insoluble aggregates.
    Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.
    Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.
    In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Olympus IgA Reagent (OSR6X171):

    Acceptance Criteria and Device Performance

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (Implied by Predicate)Reported Device Performance (Olympus IgA (OSR6X171) reagent)
    Precision (Total CV%)
    AU400/400e Sample 1As good as or better than 1.53%2.43%
    AU400/400e Sample 2As good as or better than 1.63%2.52%
    AU400/400e Sample 3As good as or better than 1.26%2.95%
    AU600/640/640e Sample 1As good as or better than 1.38%3.39%
    AU600/640/640e Sample 2As good as or better than 1.08%3.85%
    AU600/640/640e Sample 3As good as or better than 1.81%4.01%
    AU2700/5400 Sample 1As good as or better than 2.64%1.50%
    AU2700/5400 Sample 2As good as or better than 2.05%1.91%
    AU2700/5400 Sample 3As good as or better than 3.29%1.83%
    Assay Range10 to 700 mg/dL10 to 700 mg/dL
    LoQNot specified (or comparable to predicate)10 mg/dL
    Method Comparison (Linear Regression)
    InterceptComparable to 1.3 mg/dL15.1 mg/dL
    SlopeComparable to 0.9570.923
    R^2Comparable to 0.990.999
    NComparable to 94111
    RangeComparable to 54-660 mg/dL38-672 mg/dL
    Interfering Substances
    Bilirubin (AU400/400e)Interference
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