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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
    Reference & Predicate Devices
    k971418,k032525,k041133,k133122
    Predicate For
    N/A
    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 < 2.0 IU/mL; MCM2-7 % dose recovery met sponsor's required acceptance criteria.Acceptance criteria for the open vial (reconstituted) stability study were met up to the 29 days' time point, supporting an open vial claim of 28 days when properly stored at 2-8°C.
    On-Board StabilityMCM1 dose recovery ≤ 2.0 IU/mL; MCM2-7 % dose recovery met sponsor's required acceptance criteria.Acceptance criteria for the on-board stability study were met up to 5 hours, which supports an on-board stability claim for 4 hours.
    Value Assignment (MCM1)MCM1 measures at or below the IgE assay sensitivity limit. (Target: 0.0 dose)Consistent with claim: MCM1 is an analyte-free basepool and its quality control specifications ensure it measures at or below the IgE assay sensitivity limit.
    Value Assignment (MCM2-MCM7)New MCM doses must fall within the final value assignment specification for IgE MCMs. The mean MCM doses of the new MCM lot manufactured must fall within the customer range specifications.New MCM doses are calculated based on the relationship between observed reference MCM dose and its assigned value. Performance verification runs confirm meeting customer range specifications. Table 2 provides assigned target values for each MCM level, demonstrating this aspect of performance.

    2. Sample Size Used for the Test Set and the Data Provenance

    This is not applicable as the device is a quality control material, not a diagnostic test evaluated with a patient test set. The "testing" refers to internal laboratory performance studies to validate the stability and value assignment of the quality control material itself.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    Not applicable. Ground truth, in this context, relates to the accurate assignment of IgE values to the control materials, which is done through a standardized, traceable process rather than expert consensus on patient data.

    4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

    Not applicable.

    5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This is a quality control material, not an AI/ML diagnostic device for human reader assistance.

    6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

    Not applicable. This is not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    The "ground truth" for the ADVIA Centaur® IgE Master Curve Material is established through traceability to a recognized international standard: the World Health Organization (WHO) 75/502 reference material for IgE. This means the values assigned to the quality control material are linked to a globally accepted standard, ensuring consistency and accuracy.

    8. The sample size for the training set

    Not applicable. There is no "training set" as this is not an AI/ML model.

    9. How the ground truth for the training set was established

    Not applicable.

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