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    K Number
    K984130
    Device Name
    COAGULATION CONTROL LEVEL 2 (ABNORMAL)
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1998-12-01

    (13 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K771346
    Why did this record match?
    Device Name :

    COAGULATION CONTROL LEVEL 2 (ABNORMAL)

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

    Pacific Hemostasis Coagulation Control Level 2 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the moderately abnormal range.

    Device Description

    Pacific Hemostasis Coagulation Control Level 2 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.

    AI/ML Overview

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    Acceptance Criteria and Study for Coagulation Control Level 2 (Abnormal)

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the "Pacific Hemostasis Coagulation Control Level 2 (Abnormal)" device were implicitly established through comparison to a legally marketed predicate device, the "Dade Ci-Trol Coagulation Control Level II" (K771346). The primary metric for substantial equivalence was precision (both between-run and within-run), as measured by the Coefficient of Variation (CV%) and standard deviation (SD) of Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) values.

    Metric (Acceptance Criteria)Predicate Device Performance (Dade Ci-Trol Level II)Proposed Device Performance (Pacific Hemostasis Level 2)Substantial Equivalence Evaluation
    Between-run Precision (PT)CV% = 4.97, SD = 1.86, Mean = 37.3CV% = 4.29, SD = 1.76, Mean = 41.0Proposed device's CV% (4.29) is lower than predicate's (4.97), indicating comparable or better precision.
    Between-run Precision (APTT)CV% = 1.52, SD = 0.59, Mean = 39.0CV% = 2.42, SD = 1.10, Mean = 45.4Proposed device's CV% (2.42) is slightly higher than predicate's (1.52), but still within generally accepted clinical ranges for control materials (typically
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