510(k) Report

Devices descending from K140407

24 later devices reach Filmarray Gastrointestinal (GI) Panel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251721Xpert GI PanelCepheid20260—
+1K251868Panther Fusion GI Bacterial AssayHologic20250—
+1K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.20250—
+1K220062QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH20244—
+1K182703EntericBio Dx AssaySerosep, Ltd.20190—
+1K152955Great Basin Shiga Toxin Direct TestGreat Basin Scientific, Inc.20160—
+1K143648BD MAX Enteric Parasite Panel, BD MAX InstrumentBecton, Dickinson and Company201521
+1K143005FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC2015127
+2K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH20251—
+2K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH20252—
+2K243813QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH20252—
+2K232672EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited20240—
+2K220193BD MAX Enteric Parasite PanelBecton, Dickinson and Company20220—
+2K181427BD MAX Enteric Viral Panel, BD MAX InstrumentBecton, Dickinson and Company201811
+2K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC201696
+3K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…QIAGEN GmbH20260—
+3K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC202333
+3K220607BD MAX Enteric Viral PanelBecton, Dickinson and Company20220—
+3K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company201721
+4K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…Becton, Dickinson and Company20250—
+4K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC20242—
+4K214122BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial PanelBecton, Dickinson and Company20221—
+5K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation20260—
+5K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC20250—