510(k) Report

Devices descending from K121894

6 later devices reach Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142501Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert…Cepheid20141—
+1K140647Xtag Gastrointestinal Pathogen Panel (GPP)/Xtag Data Analysis Software for GPP (Tdas GPP)Luminex Molecular Diagnostics, Inc.20140—
+1K142033Verigene Enteric Pathogen Nucleic Acid Test (EP)Nanospere,Inc.201401
+1K140083Verigene Enteric Pathogen Nucleic Acid Test ( EP)Nanosphere, Inc.201415
+2K171511RIDA GENE Norovirus GI/GIIR-Biopharm AG20170—
+2K163571Great Basin Stool Bacterial Pathogens PanelGreat Basin Scientific, Inc.20170—