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    K Number
    K052264
    Device Name
    QUANTA LITE CCP3 IGG ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2005-11-23

    (96 days)

    Product Code
    NHX
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE CCP3 IGG ELISA

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

    The QUANTA Lite™ CCP3 IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the "QUANTA Lite™ CCP3 IgG ELISA" device. It does not contain details about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment.

    The letter primarily addresses the substantial equivalence determination for marketing the device. The 510(k) summary, which would contain such study details, is a separate document typically submitted with the 510(k) application.

    Therefore, I cannot provide the requested information based on the provided text.

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