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510(k) Data Aggregation

    K Number
    K981173
    Device Name
    CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (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
    K900411
    Why did this record match?
    Device Name :

    CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)

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

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

    Device Description

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

    AI/ML Overview

    The provided text describes the 510(k) summary for CryoCheck™ Factor XI Deficient Plasma, focusing on its non-clinical performance data for open vial stability.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided input:

    1. A table of acceptance criteria and the reported device performance

    Performance MetricAcceptance CriteriaReported Device Performance (Summary Statistics)
    Mean % Recovery of Factor XIMean (+/-) 5% of reference value0 Hours: 97.2%, 24 Hours: 96.2%, Average: 96.7%
    Coefficient of Variation (C.V.%)
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