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510(k) Data Aggregation

    K Number
    K082631
    Device Name
    THROMBO TEK PSE, MODEL 90-480
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2008-12-17

    (98 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K913424
    Why did this record match?
    Device Name :

    THROMBO TEK PSE, MODEL 90-480

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

    ThromboTek PSe is intended for the quantitative determination of functional Protein S activity in human plasma.

    ThromboTek PSe is intended for the quantitative determination of functional Protein S activity, such as when identifying inherited or acquired Protein S deficiency.

    Device Description

    ThromboTek PSe is a tissue factor pathway based clotting assay. The assay activator is a lyophilized preparation incorporating rabbit thromboplastin, calcium, buffer, and stabilizers. The remaining components of the assay are lyophilized activated Protein C, lyophilized human plasma depleted of Protein S, Imidazole buffered saline for use as a plasma diluent, and deionized water containing a preservative for reconstitution of the lyophilized components.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study details for the ThromboTek PSe assay, based on the provided K082631 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    FeatureAcceptance Criteria (Implied)Reported Device Performance
    PrecisionLow %CV for both normal and abnormal plasma samples.Normal Plasma: Repeatability 4.9% CV, Total 5.7% CV
    Abnormal Plasma: Repeatability 7.8% CV, Total 9.2% CV
    LinearityLinear across the clinically relevant range.Linear from 10% Protein S to 156% Protein S (maximum tested).
    Analytical SensitivityLow limit of detection for Protein S activity.1% Protein S.
    InterferencesMinimal impact from common interferants at specified concentrations (e.g.,
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