LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K063160
    Device Name
    ALLERGEAZE PATCH TEST CHAMBERS
    Manufacturer
    SMART PRACTICE
    Date Cleared
    2006-12-22

    (66 days)

    Product Code
    KXF,LDH
    Regulation Number
    880.6025
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALLERGEAZE PATCH TEST CHAMBERS

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

    Allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin

    Device Description

    Not Found

    AI/ML Overview

    This is a 510k document for the AllergEAZE™ Patch Test Chambers. This document is a clearance letter from the FDA, not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. This letter does not describe a clinical study or performance evaluation in the way a scientific paper or a more detailed regulatory submission might.

    The document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate, rather than presenting a detailed performance study with acceptance criteria and a study design.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1