LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K970933
    Device Name
    AUTO HDL CHOLESTEROL CALIBRATOR
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    1997-05-23

    (71 days)

    Product Code
    JIS
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the calibration of Pointe Scientific's autoHDL™ Cholesterol assay in serum or plasma. It is intended for in vitro diagnostic use only.

    Device Description

    autoHDL™ Cholesterol Calibrator

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the autoHDL™ Cholesterol Calibrator. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.

    The letter is a regulatory document confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not include the detailed technical study results typically found in a clinical or performance validation report. Therefore, I cannot extract the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1