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    K Number
    K112523
    Device Name
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2012-01-06

    (128 days)

    Product Code
    DHB
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K093987
    Predicate For
    K132801
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

    Device Description

    IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the IMMULITE® 2000 3gAllergy™ Specific IgE Assay, based on the provided text:

    Acceptance Criteria and Device Performance

    The study evaluates the analytical performance and clinical performance of the device.

    Analytical Performance Acceptance Criteria:

    The key acceptance criteria for analytical performance are related to precision, linearity, and specificity. While explicit quantitative criteria were provided for precision, linearity had implied criteria based on excellent regression statistics, and specificity was demonstrated by successful inhibition.

    Acceptance Criteria CategorySpecific CriteriaReported Device PerformanceComments
    PrecisionIntra-assay Variability: Less than 15% CV for all allergen lots.All allergens met this criterion. For example, nOle e 1 (Lot 201) had within-run CVs ranging from 3.95% to 6.23%.This indicates consistent results within a single test run.
    Inter-assay Precision: Less than 15% CV for all allergen lots.All allergens met this criterion. For example, nOle e 1 (Lot 201) had total CVs ranging from 5.85% to 7.03%.This indicates consistent results across multiple test runs over different days.
    Lot-to-Lot Precision: Less than 20% CV for all 5 allergens.All 5 allergens met this criterion. For example, combined nOle e 1 lots showed total CVs up to 6.94%.This demonstrates consistency of results when using different batches (lots) of the allergen.
    Negative Control: Average negative control remained negative (
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