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510(k) Data Aggregation

    K Number
    K984326
    Device Name
    ELECYS IGE ASSAY
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1999-02-08

    (67 days)

    Product Code
    JHR
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELECYS IGE ASSAY

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

    For in vitro quantitative determination of immunoglobulin E in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Determination of total serum IgE is useful as an aid in the diagnosis of allergic disease.

    Device Description

    The Elecsys® IgE test is based on the sandwich principle of heterogeneous immunological complex formation. First Step: Biotinylated monoclonal antibodies (R1) and ruthenium labeled antibodies (R2), both specific for IgE, bind IgE present in the sample forming a sandwich complex Second Step: Microparticles coated with streptavidin (M) bind the biotin portion of the complex and are captured magnetically onto the surface of the electrode. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Elecsys® IgE Test, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance:

    FeatureAcceptance Criteria (Implied / Predicate Performance)Reported Device Performance (Elecsys® IgE Test)
    PrecisionWithin-Run %CV
    Within-Run %CV:
    ~2.1% at 102.7 IU/mL
    ~2.1% at 244.1 IU/mL
    ~2.8% at 375.4 IU/mL3.6% at 5.18 IU/mL
    2.1% at 105 IU/mL
    2.8% at 197 IU/mL
    3.2% at 398 IU/mL
    2.4% at 1010 IU/mL
    Total %CVTotal %CV
    Total %CV:
    ~3.4% at 102.7 IU/mL
    ~3.4% at 244.1 IU/mL
    ~3.6% at 375.4 IU/mL4.2% at 5.18 IU/mL
    1.9% at 105 IU/mL
    3.9% at 197 IU/mL
    3.9% at 398 IU/mL
    3.1% at 1010 IU/mL
    Lower Detection Limit1.44 IU/mL (Predicate)0.10 IU/mL
    Measuring Range1.44 - 500 IU/ml (Predicate)0.10 - 4000 IU/ml
    SpecificityNo cross-reactions with IgG, IgA, and IgM (Predicate)No cross-reactivity with the immunoglobulins G, A, and M was detected.
    Method ComparisonEvidence of strong correlation (e.g., r close to 1) with the predicate device.Elecsys IgE vs Enzymun-Test IgE
    Passing/Bablok: y = -0.53 + 0.97x, r = 1.0, SD (md68) = 2.42, N = 188
    Linear regression: y = -1.85 + 1.01x, r = 1.0, Sy.x = 5.86, N = 188
    Interfering SubstancesNo interference at predicate's concentrations:
    Bilirubin
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