LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061413
    Device Name
    APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
    Manufacturer
    GEN-PROBE, INC.
    Date Cleared
    2006-10-13

    (144 days)

    Product Code
    MKZ
    Regulation Number
    866.3120
    Type
    Traditional
    Panel
    Microbiology (MI)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

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

    The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleix acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens1, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.

    1 Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Gen-Probe Incorporated regarding their TIGRIS® DTS® Automated Analyzer APTIMA® Assay for Chlamydia trachomatis. While it outlines the device's indications for use and classification, it does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

    Therefore, I cannot fulfill most of your request directly from this document. The information typically found in a 510(k) summary (which is a separate document often submitted alongside the initial notification) would contain such details.

    However, based on the information provided in this letter, I can extract the following:

    • Device Name: TIGRIS® DTS® Automated Analyzer APTIMA® Assay for Chlamydia trachomatis
    • Indications for Use: The APTIMA Assay for Chlamydia trachomatis is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) in clinician-collected endocervical, vaginal and male urethral swab specimens, patient-collected vaginal swab specimens¹, and female and male urine specimens. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of chlamydial urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.
      • ¹Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.

    To answer the rest of your questions, I would need access to the full 510(k) submission, specifically the sections detailing the performance data and clinical studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1