LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053287
    Device Name
    COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2006-08-10

    (258 days)

    Product Code
    MKZ
    Regulation Number
    866.3120
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K973718
    Why did this record match?
    Reference Devices :

    K973718

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

    The Roche Scripts for COBAS AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:

    • COBAS AMPLICOR™ CT/NG test for Chlamydia trachomatis
    • COBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae
    Device Description

    The Roche Scripts for COBAS AMPLICOR CT/NG Test accessory consists of a compact disc (CDs) containing scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis.

    AI/ML Overview

    The provided text describes a 510(k) summary for the COBAS AMPLICOR CT/NG test for Chlamydia trachomatis with Roche Scripts Accessory. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The document mainly focuses on:

    • Device description and intended use of the COBAS AMPLICOR CT/NG test.
    • Description of the Roche Scripts accessory (software) to automate sample processing.
    • Comparison to a predicate device.
    • The FDA's decision letter for 510(k) clearance, confirming substantial equivalence.
    • Indications for Use for the Roche Scripts accessory.

    There is no mention of:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used for test sets, data provenance.
    3. Number of experts or their qualifications for ground truthing.
    4. Adjudication methods.
    5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    Therefore,Based on the provided text, I cannot describe the acceptance criteria or a study that proves the device meets the acceptance criteria, as this information is not present in the document. The document primarily focuses on the description and intended use of the device and its 510(k) clearance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1