510(k) Report

Devices descending from DEN180047

12 later devices reach Aptima Mycoplasma genitalium Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202977Alinity m STI AssayAbbott Molecular, Inc.20221—
+1K190515Aptima Combo 2 Assay (Panther System)Hologic, Inc.20196—
+1K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80…Cepheid20190—
+1K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas…Roche Molecular Systems, Inc.20193—
+2K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…Roche Molecular Systems, Inc.20260—
+2K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20260—
+2K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20250—
+2K230267NeuMoDx CT/NG Assay 2.0Neumodx Molecular, Inc.20230—
+2K222379Alinity m STI AssayAbbott Molecular, Inc.202301
+2K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…Hologic, Inc.20202—
+3K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, Inc.20201—
+4K220321Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris…Hologic, Inc.20220—