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    K Number
    K200825
    Device Name
    NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
    Manufacturer
    Hycor Biomedical
    Date Cleared
    2020-06-26

    (88 days)

    Product Code
    DHB
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    k051218
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    Device Name :

    NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE

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

    The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

    Device Description

    The NOVEOS Specific IgE Assay is an immunometric, chemilyminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IqE) 11/234.

    AI/ML Overview

    This document describes the validation of the NOVEOS Specific IgE (sIgE) assays for Cat Dander (E001, Felis domesticus) and Timothy Grass (G006, Phleum pratense). This is a quantitative in vitro diagnostic device, not an AI/ML powered device. Therefore, many of the typical acceptance criteria for AI models, such as MRMC studies, ground truth establishment by experts, and training set details, are not applicable.

    The acceptance criteria for this device are based on its analytical and clinical performance when compared to a legally marketed predicate device (ImmunoCAP Specific IgE Assay) and clinical diagnosis.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally implied by the performance metrics reported and the statistical analysis acceptable for FDA clearance of an in vitro diagnostic device of this type. The key performance indicators for a quantitative assay would typically include linearity, precision (imprecision/reproducibility), agreement with a predicate device, and clinical concordance (sensitivity and specificity).

    Performance Table for NOVEOS Specific IgE (sIgE) Assays

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance (E001 - Cat Dander)Reported Device Performance (G006 - Timothy Grass)
    Agreement with PredicateTo demonstrate substantial equivalence, percentages should be high (e.g., >90% for PPA and >95% for NPA, or similar ranges). Precision of CI is also important.PPA: 91.8% (95% CI: 84.6% – 95.8%)
    NPA: 99.3% (95% CI: 96.1% to 99.9%)
    (Cut-off: 0.35 kU/L)PPA: 86.4% (95% CI: 78.5% to 91.7%)
    NPA: 98.5% (95% CI: 94.6% to 99.6%)
    (Cut-off: 0.35 kU/L)
    Clinical PerformanceClinical sensitivity and specificity should demonstrate adequate diagnostic accuracy. Typical acceptance ranges for IVDs might be >70-80% for sensitivity and >90% for specificity, depending on the clinical context.Sensitivity: 75.7% (95% CI 64.5% to 84.2%)
    Specificity: 100% (95% CI 97.1% to 100%)Sensitivity: 76.2% (95% CI 64.4% to 85.0%)
    Specificity: 99.2% (95% CI 95.6% to 99.9%)
    Imprecision/ReproducibilityTotal CV% should generally be low, typically 0.99) and slope close to 1.0 with intercept close to 0, within the claimed measuring interval.R2: 0.999
    Slope: 1.00 (95% CI: 0.98 to 1.01)
    Intercept: -0.37 (95% CI: -0.79 to -0.05)
    Range: 0.03 - 101.62 kU/LR2: 0.997
    Slope: 1.02 (95% CI: 0.99 to 1.05)
    Intercept: 0.58 (95% CI: -0.36 to 1.51)
    Range: 0.06 - 104.99 kU/L
    Detection LimitLoQ (Limit of Quantitation) should be defined and acceptable for clinical use, typically 0.14 kU/L for specific IgE assays to distinguish very low positive from negative (this is often the action limit for clinical use). LoB and LoD values should be reported.LoB: 0.02 kU/L
    LoD: 0.06 kU/L
    LoQ: 0.14 kU/LLoB: 0.03 kU/L
    LoD: 0.06 kU/L
    LoQ: 0.14 kU/L
    Interference/Cross-ReactivityInterference from common endogenous/exogenous substances and cross-reactivity with other related/unrelated allergens or immunoglobulins should be demonstrated to be minimal (e.g.,
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