FDA Product Code PCH: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
FDA product code PCH covers gastrointestinal pathogen panel multiplex nucleic acid tests.
These assays simultaneously detect and identify multiple bacterial, viral, and parasitic pathogens responsible for infectious diarrhea — including Salmonella, Campylobacter, norovirus, Cryptosporidium, and others — from a single stool sample. Multiplex panels replace sequential single-target tests with a single comprehensive result.
PCH devices are Class II medical devices, regulated under 21 CFR 866.3990 and reviewed by the FDA Microbiology panel.
Leading manufacturers include QIAGEN GmbH, Biofire Diagnostics, LLC and Becton, Dickinson and Company.
FDA 510(k) Cleared Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System Devices (Product Code PCH)
About Product Code PCH - Regulatory Context
510(k) Submission Activity
37 total 510(k) submissions under product code PCH since 2013, with 36 receiving FDA clearance (average review time: 150 days).
Submission volume has increased in recent years - 12 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PCH have taken an average of 167 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.
PCH devices are reviewed by the Microbiology panel. Browse all Microbiology devices →