LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030679
    Device Name
    MAS LIPID LEVEL 1 AND 2
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    2003-03-14

    (10 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

    The MAS® Lipid control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many lipid determinations. Include MAS® Lipid control 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 an FDA 510(k) clearance letter for a device named "MAS® Lipid Control." This document is a regulatory communication and does not contain the acceptance criteria, study details, or performance data requested in the prompt.

    The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls.

    Therefore, I cannot provide accurate answers to the questions based on the given input text. The information requested (acceptance criteria, study details, sample sizes, expert qualifications, etc.) would typically be found in the 510(k) submission itself, not in the clearance letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1