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510(k) Data Aggregation

    K Number
    K042550
    Date Cleared
    2004-11-08

    (49 days)

    Product Code
    Regulation Number
    862.1150
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MULTI-LIPID CALIBRATOR

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

    The Multi-Lipid Calibrator is designed to be used with Wako's assays to determine the points of reference that are used in the determination of HDL-C, LDL-C, Cholesterol, and Triglycerides in human serum.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter for a medical device called "Multi-Lipid Calibrator." Based on the provided text, there is no information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt.

    The document is an FDA clearance letter stating that the device is substantially equivalent to a legally marketed predicate device. It defines the device, its intended use, and acknowledges that the manufacturer can market it subject to general controls.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for the test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance study results.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This information is typically found in the 510(k) submission itself (which is not provided here) or in accompanying performance studies, not in the clearance letter.

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