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510(k) Data Aggregation

    K Number
    K980888
    Device Name
    GLYCACOR
    Manufacturer
    EXOCELL, INC.
    Date Cleared
    1998-08-13

    (157 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Enzyme linked Immunosorbent Assay (ELISA), non-radioactive, for determination of glycated LDL (low-density lipoprotein) in plasma

    Device Description

    Not Found

    AI/ML Overview

    The provided text {0} {1} {2} is an FDA 510(k) clearance letter for a device named "Glycacor" and does not contain the specific information required to answer the prompt.

    The document states that the Glycacor device is an "Enzyme linked Immunosorbent Assay (ELISA), non-radioactive, for determination of glycated LDL (low-density lipoprotein) in plasma." It confirms that the FDA reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices.

    However, the letter does not include:

    1. Acceptance criteria or reported device performance.
    2. Details on sample sizes, data provenance, or expert qualifications for any study.
    3. Adjudication methods.
    4. Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
    5. The type of ground truth used or how it was established.
    6. The sample size for the training set.

    Therefore, I cannot provide the requested table and study details based on the given information. The document is strictly an FDA clearance letter and not a performance study report.

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