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    K Number
    K031890
    Device Name
    MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    2003-07-16

    (28 days)

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

    MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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

    MAS® Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "MAS® Bilirubin – Liquid Assayed Bilirubin Control." This device is a quality control material and not a diagnostic or AI-powered device that would typically undergo the types of studies you are asking about (test sets, training sets, expert ground truth, MRMC studies, etc.).

    Therefore, the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and comparative effectiveness studies cannot be extracted from this document.

    The document primarily focuses on:

    • Device Name: MAS® Bilirubin – Liquid Assayed Bilirubin Control
    • Regulation Number: 21 CFR 862.1660 (Quality control material)
    • Regulatory Class: Class I
    • Product Code: JJX
    • Indications for Use: "MAS® Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument."

    This is a quality control material, meaning its purpose is to verify the performance of other analytical instruments and reagents in a laboratory setting. Its "performance" is about its stability, consistency, and having accurately assigned values, not about diagnostic accuracy or the performance of an algorithm.

    In summary, none of the requested information regarding acceptance criteria derived from a diagnostic study, test sets, training sets, or expert ground truth is present in this FDA clearance letter because the device is a quality control material, not a diagnostic device or AI model.

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