510(k) Report

Devices descending from K043144

10 later devices reach Gen-Probe Aptima Assay for Neisseria Gonorrhoeae through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80…Cepheid20190—
+1K121710Xpert CT/NGCepheid201273
+1K090971BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO200901
+1K080739Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection KitAbbott Molecular, Inc.20080—
+2K200748Visby Medical Sexual HealthVisby Medical20212—
+2K173840Xpert CT/NGCepheid20181—
+2K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid20154—
+3K220407Visby Medical Sexual Health TestVisby Medical20231—
+3K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…Cepheid20160—
+4K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.20250—