LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040880
    Device Name
    MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    2004-04-28

    (23 days)

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

    MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3

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

    The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control scrum suitable for monitoring assay conditions in specific cardiac marker determinations. Include this product 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 cardiac marker control device. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets performance criteria in the way a diagnostic or AI-driven device would. The device, "MAS® CardioImmune® TL Liquid Assayed Cardiac Marker Control Level 1, 2 and 3," is a quality control material intended for use in clinical laboratories to monitor assay conditions for cardiac marker determinations.

    Therefore, I cannot provide the requested information for acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information is not typically part of a 510(k) clearance letter for a quality control material.

    The letter primarily focuses on:

    • Substantial equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
    • Device classification: Class I.
    • Intended Use: "intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations."

    The clearance process for a quality control material like this primarily involves demonstrating that it performs as intended for quality control without significant safety or effectiveness concerns, often through comparisons to existing, similar products rather than extensive clinical efficacy trials as you would see for a diagnostic test.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1