510(k) Report

Devices descending from K122062

11 later devices reach Aptima Trichomonas Vaginalis Assay - Panther through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231316Aptima Trichomonas vaginalis AssayHologic, Inc.20230—
+1K220321Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris…Hologic, Inc.20220—
+1K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…Hologic, Inc.20202—
+1K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid20154—
+1K143329AmpliVue Trichomonas AssayQuidel Corporation20151—
+2K200748Visby Medical Sexual HealthVisby Medical20212—
+2K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, Inc.20201—
+2K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…Cepheid20160—
+2K161182Solana Trichomonas AssayQuidel Corporation20160—
+3K220407Visby Medical Sexual Health TestVisby Medical20231—
+4K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.20250—