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510(k) Data Aggregation

    K Number
    K024210
    Device Name
    IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2003-02-24

    (66 days)

    Product Code
    DGC
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K930984
    Why did this record match?
    Device Name :

    IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR

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

    Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.

    Device Description

    Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.

    AI/ML Overview

    The presented document is a 510(k) summary for the IMMAGE® Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Calibrator, submitted by Beckman Coulter, Inc. It describes the device, its intended use, comparison to a predicate device, and a summary of performance data.

    Here's an analysis of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, r-value, or imprecision percentages. Instead, it presents the results of method comparison and imprecision studies as evidence of substantial equivalence to the predicate device. The implied acceptance is that the device's performance is comparable to or within expected variations for such assays, as demonstrated by the presented data.

    Study TypeMetricAcceptance Criteria (Implied)Reported Device PerformanceComments
    Method ComparisonSlopeClose to 1.01.06Indicates good correlation between the IMMAGE system and the predicate Access Total IgE system.
    InterceptClose to 02.75A small intercept indicates minimal systematic bias.
    r (correlation coefficient)High (e.g., >0.95)0.991Demonstrates strong linear correlation with the predicate method.
    n (sample size)Adequacy for statistical significance125Generally considered a reasonable sample size for method comparison in diagnostic assays.
    Imprecision%CV (Within-Run)
    Level 1Low (e.g., typically
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