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510(k) Data Aggregation

    K Number
    K993098
    Device Name
    HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
    Manufacturer
    DATA MEDICAL ASSOCIATES, INC.
    Date Cleared
    1999-10-08

    (22 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HDL-C/LDL-C CALIBRATOR, MODEL 1913-003

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

    For the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDL Cholesterol and LDL Cholesterol in serum.

    Device Description

    DMA's HDL Cholesterol and LDL Cholesterol calibrator is intended for the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDLC and LDLC in serum.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device called "DMA HDL Cholesterol and LDL Cholesterol Calibrator." It describes the device's intended use and technological characteristics in comparison to a predicate device. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes (for training or test sets), expert qualifications, or ground truth establishment relevant to the device's performance.

    The document is a regulatory submission summarizing the device's purpose and its substantial equivalence to a predicate device for FDA clearance. It does not include the actual study data or the detailed acceptance criteria and performance results that would be part of a full study report.

    Therefore, I cannot provide the requested information from this document.

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