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510(k) Data Aggregation

    K Number
    K102908
    Device Name
    NOFACT IX
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2011-12-19

    (444 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K933432
    Why did this record match?
    Reference Devices :

    K933432

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

    NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

    Device Description

    NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplast time. For in vitro diagnostic use.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the NoFact IX Deficient Plasma device:

    Important Note: The provided document is a 510(k) summary for an in vitro diagnostic device, specifically a deficient plasma product used in laboratory tests. It is not an AI or imaging device, and therefore many sections of your request (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone performance") are not applicable to this type of medical device submission. I will address only the relevant information from the document.

    Acceptance Criteria and Device Performance for NoFact IX Deficient Plasma

    The device, NoFact IX Deficient Plasma, is an in vitro diagnostic intended for the quantitative determination of Factor IX activity. Its performance is demonstrated through a comparison study with a legally marketed predicate device (STA Deficient IX) and precision testing.

    1. Table of Acceptance Criteria and Reported Device Performance

    Since this is a 510(k) for an in vitro diagnostic, the "acceptance criteria" are not explicitly stated with numerical thresholds in the provided summary in the same way they might be for an AI model. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device through a strong correlation in quantitative measurements and acceptable precision. The reported performance metrics are derived from this equivalence study and precision assessment.

    Performance MetricAcceptance Criteria (Implied for Substantial Equivalence)Reported Device Performance (NoFact IX vs. Predicate)
    Comparative Study (Linear Regression)All Labs (N=233)
    - Coefficient of Determination (r²)Strong correlation with predicate device (typically r² > 0.90 is desired for quantitative comparison)0.915
    - Correlation Coefficient (r)Strong linear relationship0.956
    - SlopeClose to 1 (indicating proportional agreement)0.858
    - InterceptClose to 0 (indicating minimal constant bias)5.729
    Precision (CV%) - Normal ControlAcceptable within-run and lot-to-lot variability for an IVD measuring coagulation factors (target typically
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