510(k) Report

Devices descending from K130470

10 later devices reach BD Max Cdiff Assay, BD Max Instrument through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172569GenePOC CDiffGenepoc, Inc.201711
+1K163085Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC20170—
+1K142422cobas Cdiff TestRoche Molecular Systems, Inc.20155—
+1K132726Iceplex C. Difficile Assay Kit, Iceplex SystemPrimeradx20130—
+2K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA20230—
+2K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20174—
+3K212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20212—
+3K210385cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20210—
+4K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…Roche Molecular Systems, Inc.20260—
+4K243730Xpert C. difficile/EpiCepheid®20250—