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510(k) Data Aggregation

    K Number
    K971406
    Device Name
    ACCURUN 120 HAV IGG POSITIVE CONTROL
    Manufacturer
    BOSTON BIOMEDICA, INC.
    Date Cleared
    1997-08-07

    (113 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Boston Biomedica intends to manufacture and market ACCURUN 120 HAV IgG Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Hepatitis A Virus (HAV). This control is not intended as a substitute for controls provided with test kits.

    This product will be made available to clinical laboratory professionals in blood banks, public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to HAV in human serum and plasma.

    Device Description

    ACCURUN 120 HAV IgG Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Hepatitis A Virus (HAV).

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "ACCURUN™ 120 HAV IgG Positive Control". This document grants market clearance based on substantial equivalence to a predicate device. It explicitly states that the device is a "human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Hepatitis A Virus (HAV)".

    This document is a regulatory approval letter and does not contain the detailed study data, acceptance criteria, or performance metrics that would typically be found in a study report or scientific publication.

    Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them because this information is not present within the provided text.

    Based on the information available, I can only state the following:

    • Device Name: ACCURUN™ 120 HAV IgG Positive Control
    • Intended Use: A human blood-based single analyte run control for use with in vitro diagnostic tests for the detection of IgG antibodies to HAV in human serum and plasma. It is not intended as a substitute for controls provided with test kits.
    • Regulatory Status: Cleared by the FDA as substantially equivalent (K971406/S1).
    • Date of Clearance: August 7, 1997.
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