510(k) Report

Devices descending from K081920

18 later devices reach BD Geneohm Cdiff Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130470BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)2013102
+1K113433Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc.20120—
+1K110203Xpert C. Difficle/Epi AssayCepheid20111—
+1K091109Xpert C. DifficileCepheid20095—
+1K090239Progastro CD AssayProdesse, Inc.20090—
+2K172569GenePOC CDiffGenepoc, Inc.201711
+2K163085Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC20170—
+2K142422cobas Cdiff TestRoche Molecular Systems, Inc.20155—
+2K132726Iceplex C. Difficile Assay Kit, Iceplex SystemPrimeradx20130—
+2K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc.201204
+2K100818Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit…Meridian Bioscience, Inc.20102—
+3K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA20230—
+3K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20174—
+3K110012Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc.201112
+4K212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20212—
+4K210385cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20210—
+5K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…Roche Molecular Systems, Inc.20260—
+5K243730Xpert C. difficile/EpiCepheid®20250—