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510(k) Data Aggregation

    K Number
    K971222
    Device Name
    CRYO CHECK APC RESISTANT PLASMA
    Manufacturer
    PRECISION BIOLOGICALS, INC.
    Date Cleared
    1997-08-19

    (139 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CRYO CHECK APC RESISTANT PLASMA

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

    CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.

    Device Description

    CryoCheck APC Resistant Plasma

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "CRYOV CHECK™ APC RESISTANT PLASMA." It confirms that the device is substantially equivalent to a predicate device and can be marketed.

    However, the document does not contain any information about acceptance criteria for device performance, nor does it detail any study that proves the device meets specific performance criteria. It is a regulatory approval document, not a scientific study report.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The requested information (sample size, data provenance, expert details, adjudication, MRMC study, standalone performance, ground truth, training set size, training set ground truth) is not present in this regulatory letter.

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