510(k) Report

Devices descending from DEN110012

20 later devices reach Aptima Trichomonas Vaginalis Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+1K130268BD Probetec Trichomonas Vaginalis (TV) QX Amplified Dna AssayBecton, Dickinson & CO20137—
+1K122062Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc.201311—
+2K231316Aptima Trichomonas vaginalis AssayHologic, Inc.20230—
+2K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, Inc.20201—
+2K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company201662
+2K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid20154—
+2K143329AmpliVue Trichomonas AssayQuidel Corporation20151—
+3K202977Alinity m STI AssayAbbott Molecular, Inc.20221—
+3K200748Visby Medical Sexual HealthVisby Medical20212—
+3K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company20193—
+3K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…Cepheid20160—
+3K161182Solana Trichomonas AssayQuidel Corporation20160—
+4K220407Visby Medical Sexual Health TestVisby Medical20231—
+4K222379Alinity m STI AssayAbbott Molecular, Inc.202301
+4K210585BD CTGCTV2Becton, Dickinson and Company202211
+4K193081Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software)…Rheonix, Inc.20210—
+5K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.20250—
+5K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,20250—