510(k) Report

Devices descending from K121710

7 later devices reach Xpert CT/NG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200748Visby Medical Sexual HealthVisby Medical20212—
+1K173840Xpert CT/NGCepheid20181—
+1K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid20154—
+2K220407Visby Medical Sexual Health TestVisby Medical20231—
+2K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80…Cepheid20190—
+2K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…Cepheid20160—
+3K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.20250—