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510(k) Data Aggregation

    K Number
    K040362
    Device Name
    DIAPHARMA FACTOR X KIT
    Manufacturer
    DIAPHARMA GROUP, INC.
    Date Cleared
    2004-07-12

    (150 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAPHARMA GROUP, INC.

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

    The DiaPharma Factor X Kit is an in vitro diagnostic test kit for the quantitative determination of Factor X activity in human citrated plasma.

    Factor X activity is useful for monitoring patients on oral anticoagulant therapy (warfarin) where baseline PT values may be prolonged and INR results are not reliable, such as in OAC patients with lupus inhibitors. The DiaPharma FX kit provides health care providers with a tool for with Tapac Innovelor The DiaPharma Factor X Kit is also useful for screening for factor X deficiencies.

    Device Description

    Not Found

    AI/ML Overview

    The provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. This document is a 510(k) premarket notification letter from the FDA to DiaPharma Group, Inc. for their DiaPharma Factor X Kit. It primarily confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory compliance requirements.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study demonstrating compliance. This type of detailed performance data is typically found in a clinical study report or a more extensive technical file, not in the FDA's initial 510(k) clearance letter.

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