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510(k) Data Aggregation

    K Number
    K990149
    Device Name
    ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01
    Manufacturer
    BIO-RAD
    Date Cleared
    1999-01-26

    (7 days)

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

    Abbott Liquid Pediatric Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for the "Abbott Liquid Pediatric Chemistry Control" device. This device is a quality control material and not an AI/ML medical device. Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) related to AI/ML device evaluation is not applicable to this document.

    The document only states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market. The FDA's review in this case focuses on equivalence, not on a detailed performance study with acceptance criteria as would be required for a novel AI/ML device.

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