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510(k) Data Aggregation

    K Number
    K981174
    Device Name
    CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1999-01-13

    (287 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K900412
    Why did this record match?
    Device Name :

    CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)

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

    CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.

    Device Description

    Cryo✓Check™ Factor XII Deficient Plasma is frozen human plasma deficient in the Factor XII coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XII by immunoadsorption. Activity levels of Factor XII are assayed at less than 1% normal levels while all other coagulation factors are greater than 50%.

    AI/ML Overview

    Acceptance Criteria and Study Details for Cryo✓Check™ Factor XII Deficient Plasma

    The device's performance was evaluated through an "Open Vial Stability" study.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance (24 Hours)
    Mean (+/-) 5% of reference value93 (within 5% of reference value, as 92.9% is the overall average)
    %C.V.
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