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510(k) Data Aggregation

    K Number
    K971657
    Device Name
    ACCURUN 121 HAV IGM POSITIVE CONTROL
    Manufacturer
    BOSTON BIOMEDICA, INC.
    Date Cleared
    1997-08-12

    (98 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 121 HAV IGM POSITIVE CONTROL

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

    Boston Biomedica intends to manufacture and market ACCURUN 121 HAV IgM 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 IgM 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 virro diagnostic tests for the detection of IgM antibodies to HAV in human serum and plasma.

    Device Description

    human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV).

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called ACCURUN™ 121 HAV IgM Positive Control. It does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance results.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The document describes the intended use of the device: "a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Hepatitis A Virus (HAV)." It also mentions that the product will be available to clinical laboratory professionals for use with in vitro diagnostic tests. This indicates the device is a control material for diagnostic tests, not a diagnostic test itself or an AI-powered device.

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