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510(k) Data Aggregation

    K Number
    K033865
    Device Name
    IDEIA PCE CHLAMYDIA
    Manufacturer
    DAKOCYTOMATION LTD
    Date Cleared
    2004-01-21

    (40 days)

    Product Code
    LJC
    Regulation Number
    866.3120
    Type
    Special
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DAKOCYTOMATION LTD

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

    DakoCytomation Ltd IDEIA™ PCE Chlamydia is an immunoassay utilising dual amplification technology for the qualitative detection of Chlamydia lipopolysaccharide antigen in human urethral and endocervical swabs and male urines.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the IDEIA™ PCE Chlamydia immunoassay. It does not contain the detailed study information regarding acceptance criteria or device performance that you are requesting.

    The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means it has been determined to be as safe and effective as a previously cleared device. However, it does not provide the specific performance data, acceptance criteria, or study details that would typically be found in a clinical study report or a more comprehensive submission document.

    Therefore, I cannot provide the information requested in your prompt based on the provided text. To answer your questions, I would need a different type of document, such as a detailed clinical study report, a premarket notification summary, or the full 510(k) submission.

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