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    K Number
    K992278
    Device Name
    HEPARIN CONTROL PLASMA LEVEL 1
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1999-08-26

    (50 days)

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

    HEPARIN CONTROL PLASMA LEVEL 1

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

    Pacific Hemostasis Heparin Control Plasma Level 1, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the slightly abnormal range.

    Device Description

    Pacific Hemostasis Heparin Control Level 1 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Heparin Control Plasma Level 1:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Stated or Implied)Reported Device Performance
    Precision:
    - Between-run CV
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