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510(k) Data Aggregation

    K Number
    K132722
    Device Name
    HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2014-01-22

    (145 days)

    Product Code
    GJS,GIS
    Regulation Number
    864.7750
    Type
    Special
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Hemos!L RecombiPlasTin 2G is a high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibringgen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The text is an FDA 510(k) clearance letter for the HemosIL RecombiPlasTin 2G device, stating its substantial equivalence to a predicate device and outlining regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or ground truth establishment.

    To answer your request, I would need a document that specifically details the performance evaluation of the HemosIL RecombiPlasTin 2G, including its acceptance criteria and the results of a study.

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