510(k) Report

Devices descending from K160459

9 later devices reach FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251868Panther Fusion GI Bacterial AssayHologic20250—
+1K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.20250—
+1K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC202333
+1K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company201721
+2K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…Becton, Dickinson and Company20250—
+2K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC20242—
+2K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company20221—
+3K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation20260—
+3K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC20250—