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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
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K900412

    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. < 5%3.4% (for 24 hours)

    2. Sample Size and Data Provenance

    • Sample Size for Test Set: 5
    • Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that Precision Biologicals Incorporated is located in Dartmouth, Nova Scotia, Canada, it is likely the study was conducted in Canada. The nature of stability testing suggests it was a prospective study.

    3. Number and Qualifications of Experts for Ground Truth

    Not applicable. This study focuses on the stability of a diagnostic reagent, not on interpreting images or clinical cases that would require expert consensus for ground truth. The "ground truth" reference value would be established by the assay's own internal standards.

    4. Adjudication Method

    Not applicable. The study involved quantitative measurements of factor XII activity, not subjective assessments requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. This is not a study comparing human readers with and without AI assistance. It's a stability study for a diagnostic reagent.

    6. Standalone Performance

    The study primarily evaluates the standalone performance of the Cryo✓Check™ Factor XII Deficient Plasma in terms of its ability to maintain its reference value over time.

    7. Type of Ground Truth Used

    The ground truth used is a reference value established by the assay itself. The document states "Reference Value =" and implies the reported mean, maximum, and minimum values are compared against this reference. The specific method for determining this absolute reference value is not detailed, but it would typically involve calibrating against known standards.

    8. Sample Size for Training Set

    Not applicable. This is not a machine learning or AI-based device that requires a training set.

    9. How Ground Truth for Training Set was Established

    Not applicable. No training set was used.

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