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510(k) Data Aggregation

    K Number
    K041891
    Device Name
    MININEPH HUMAN RHEUMATOID FACTOR KIT
    Manufacturer
    THE BINDING SITE
    Date Cleared
    2004-11-05

    (116 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This kit is designed for the In Vitro measurement of human mulcations for 050. This in to assigned in NINEPH. Measurement of Rheumatoid Factor may aid in the diagnosis of rheumatoid arthritis.

    Device Description

    Minineph Human Rheumatoid Factor Kit

    AI/ML Overview

    This is a 510(k) clearance letter for the Minineph Human Rheumatoid Factor Kit, an in vitro diagnostic device used to aid in the diagnosis of rheumatoid arthritis. The document does not contain the detailed study information regarding acceptance criteria and device performance that you are requesting.

    Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in the 510(k) submission summary or associated clinical study reports, which are not included in this document.

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