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510(k) Data Aggregation

    K Number
    K972048
    Device Name
    ACCURUN 117 HBEAG POSITIVE CONTROL
    Manufacturer
    BOSTON BIOMEDICA, INC.
    Date Cleared
    1997-08-12

    (71 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCURUN 117 HBEAG POSITIVE CONTROL

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

    ACCURUN 117 HBeAg Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits.

    ACCURUN 117 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

    Device Description

    ACCURUN 117 HBeAg Positive Control is a human blood based single analyte run control.

    AI/ML Overview

    This document is a letter from the FDA regarding a 510(k) notification for a medical device. It does not contain specific information about acceptance criteria, device performance study details, or ground truth establishment.

    Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on the regulatory approval of the ACCURUN™ 117 HBeAg Positive Control and its classification.

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