510(k) Report

Devices descending from K092953

8 later devices reach Xpert VanA Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243405Xpert vanACepheid®20240—
+1K152614Xpert Carba-RCepheid20166—
+2K191288Acuitas AMR Gene PanelOpgen, Inc.20210—
+2K190275GenePOC CarbaGenepoc, Inc.20190—
+2K160901Xpert Carba-RCepheid20163—
+3K190613BD MAX Check-Points CPOCheck-Points Health B.V.20190—
+3K173263Xpert Carba-RCepheid20181—
+4K261867Xpert Carba-RCepheid®20260—