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Updated: Mar 30, 2026

Multiplex Detection of Bacteria in Complex Clinical and Environmental Samples using Oligonucleotide-coupled Fluorescent Microspheres
11:09

Multiplex Detection of Bacteria in Complex Clinical and Environmental Samples using Oligonucleotide-coupled Fluorescent Microspheres

Published on: October 23, 2011

16.8K

Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex

    Federal Register
    |November 4, 2015
    PubMed

    Insights

    The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II. This classification ensures the device

    Area of Science:

    • Medical Diagnostics
    • Microbiology
    • Molecular Biology

    Background:

    • Gastrointestinal infections pose a significant public health challenge.
    • Accurate and rapid detection of gastrointestinal microorganisms is crucial for effective treatment.
    • Nucleic acid-based assays offer high sensitivity and specificity for pathogen identification.

    Purpose of the Study:

    • To classify a novel gastrointestinal microorganism multiplex nucleic acid-based assay.
    • To establish regulatory controls for this diagnostic device.
    • To ensure the safety and effectiveness of the assay for clinical use.

    Main Methods:

    • Regulatory classification by the Food and Drug Administration (FDA).
    • Assessment of the device's intended use and technological characteristics.
    • Determination of appropriate regulatory controls.

    Main Results:

    • The gastrointestinal microorganism multiplex nucleic acid-based assay is classified into class II.
    • Special controls will be implemented to ensure safety and effectiveness.
    • This classification facilitates the device's availability to healthcare providers.

    Conclusions:

    • Class II classification with special controls provides a clear regulatory pathway.
    • This ensures that the diagnostic assay meets rigorous standards for performance.
    • The classification supports the reliable diagnosis and management of gastrointestinal infections.

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