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Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens - Class II Special Controls Guideline for Industry and Food and Drug Administration Staff

Read the Special Controls Document

Issue Date: 11/02/2015

Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health Division of Microbiology Devices

This special controls guideline was developed to support the classification of a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls).

This guideline identifies measures that FDA believes will mitigate the risks to health associated with these devices and provide a reasonable assurance of safety and effectiveness. Firms submitting a 510(k) for a gastrointestinal microorganism multiplex nucleic acid-based assay will need either to (1) comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness.