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510(k) Data Aggregation

    K Number
    K990814
    Device Name
    CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
    Manufacturer
    PRECISION BIOLOGIC
    Date Cleared
    1999-06-07

    (88 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K900906
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cryov Check™ Factor 2 Deficient Plasma is recommended for use as a substrate in clot-based factor II assays using the one stage prothrombin time (PT) assay.
    Cryov Check™ Factor 2 Deficient Plasma is human plasma deficient in the Factor II coagulation protein while having all other coagulation factors within normal limits. It is recommended for use as a substrate in clot-based Factor II assays using the one stage prothrombin time (PT).

    Device Description

    CryovCheck™ Factor 2 Deficient Plasma is frozen human plasma deficient in the Factor II coagulation protein. It is prepared from citrated pooled normal human plasma which has been depleted of Factor II by immunoadsorption. Activity levels of Factor II are assayed at less than 1% normal levels while all other coagulation factors are within normal levels.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Factor II activity levelLess than 1% normal levels
    All other coagulation factorsWithin normal limits
    24-hour open vial stability (PT and APTT assays)No anomalous results detected
    24-hour open vial stability (Factor II recovery, Mean (% recovery), 2 SD, CV%)Mean Factor II recovery: 83.07% (Reference Value = 85%). Max: 87%, Min: 80%. Acceptable values are: Mean (+/-) 5% of reference value (80.75% - 89.25%); and %C.V.
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