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510(k) Data Aggregation

    K Number
    K981785
    Device Name
    C4 MININEPH ANTISERUM
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-12-20

    (579 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    C4 MININEPH ANTISERUM

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

    This assay is designed for the in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, the information you are requesting about acceptance criteria and a study proving a device meets these criteria is not present. The document is an FDA 510(k) clearance letter for a device called "C4 Minineph Antiserum." It confirms the device's substantial equivalence to a predicate device and its regulatory classification, but it does not detail:

    • Specific acceptance criteria for performance metrics.
    • A study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance, expert qualifications, or adjudication methods.
    • Results of MRMC comparative effectiveness or standalone studies.
    • How ground truth was established for training or test sets.

    The document primarily states the device's "Indications for Use" which is for "in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism."

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