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510(k) Data Aggregation

    K Number
    K012576
    Device Name
    CIC-C1Q EIA
    Manufacturer
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Date Cleared
    2002-01-29

    (173 days)

    Product Code
    DAK
    Regulation Number
    866.5240
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CIC-C1Q EIA

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

    The CIC-C1q EIA is intended for the quantitative determination of circulating immune complexes (CIC) in serum or plasma.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "ALPCO Diagnostic's CIC-C1q EIA". This letter grants regulatory approval based on substantial equivalence to a predicate device. It does not contain any information about specific acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies.

    The document states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This means the FDA found that the device is as safe and effective as a device already on the market, by relying on the predicate device's established safety and effectiveness.

    Therefore, I cannot fulfill your request for the specific details of acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

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