510(k) Report

Devices descending from K935296

21 later devices reach Clostridium Difficile Tox-B Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082499C. Diff Quik Chek CompleteTechlab, Inc.20090—
+1K081920BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.)2008184
+1K050891Tox a/B Quick ChekTechlab, Inc.20051—
+2K130470BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)2013102
+2K113433Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc.20120—
+2K110203Xpert C. Difficle/Epi AssayCepheid20111—
+2K091109Xpert C. DifficileCepheid20095—
+2K090239Progastro CD AssayProdesse, Inc.20090—
+3K172569GenePOC CDiffGenepoc, Inc.201711
+3K163085Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC20170—
+3K142422cobas Cdiff TestRoche Molecular Systems, Inc.20155—
+3K132726Iceplex C. Difficile Assay Kit, Iceplex SystemPrimeradx20130—
+3K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc.201204
+3K100818Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit…Meridian Bioscience, Inc.20102—
+4K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA20230—
+4K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20174—
+4K110012Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc.201112
+5K212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20212—
+5K210385cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20210—
+6K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…Roche Molecular Systems, Inc.20260—
+6K243730Xpert C. difficile/EpiCepheid®20250—