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510(k) Data Aggregation

    K Number
    K993839
    Device Name
    ENA PROFILE ELISA TEST SYSTEM
    Manufacturer
    TRINITY BIOTECH USA
    Date Cleared
    2000-01-12

    (61 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENA PROFILE ELISA TEST SYSTEM

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

    The Trinity Biotech Captia ENA Profile Enzyme-Linked Immunosorbent Assays (ELISA) is intended for the detection of antibodies to individually coated Smith, Sm/RNP, SS-A (Ro), SS-B (La), Scl-70 and Jo-1 in a single serum specimen. The results of the assay are to be used as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE), scleroderma, Sjogren's syndrome (SS), or other systemic rheumatic diseases.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report. As such, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the way a scientific publication or a full regulatory submission would.

    Therefore, I cannot extract the requested information. The document focuses on regulatory approval, stating that the device is "substantially equivalent" to a legally marketed predicate device, rather than providing a detailed breakdown of a clinical study demonstrating its performance against specific acceptance criteria.

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