LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K143680
    Device Name
    ADVIA Centaur IgE Master Curve Material
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Date Cleared
    2015-01-27

    (34 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    k971418,k032525,k041133,k133122
    Why did this record match?
    Device Name :

    ADVIA Centaur IgE Master Curve Material

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

    The ADVIA Centaur® IgE Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Total IgE assay.

    Device Description

    ADVIA Centaur® IgE Master Curve Material is an in vitro diagnostic product containing various levels of IgE spiked in lyophilized human plasma with sodium azide (0.1%) and preservatives. Each set contains seven levels (MCM1–7); with a reconstituted volume of 1.0 mL/vial per level. MCM1 contains no analyte. The MCMs assigned values are lot-specific of target values: 0.0, 12.5, 40.0, 270, 1000, 1700, and 3150 IU/mL.

    AI/ML Overview

    This document describes the ADVIA Centaur® IgE Master Curve Material (MCM), a quality control material used for in vitro diagnostic verification of calibration and reportable range of the ADVIA Centaur Total IgE assay. It is not an AI/ML device, and therefore several of the requested sections (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, data provenance) are not applicable.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The device is a quality control material, not a diagnostic test with metrics like sensitivity or specificity. Its performance is measured by its stability and its ability to be correctly value-assigned.

    Performance MetricAcceptance Criteria (Sponsor's Required Acceptance Criteria)Reported Device Performance
    Real Time/Shelf Life StabilityMCM1 dose recovery ≤ 2.0 IU/mL; MCM2-7 % dose recovery met sponsor's required acceptance criteria.Current testing meets the sponsor's acceptance criteria for the real-time stability study up to the 9 months' time point, supporting an 8-month shelf-life claim when stored unopened at 2-8°C.
    In-Use Open Vial (Reconstituted) StabilityMCM1 dose recovery
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1