510(k) Report

Devices descending from K190515

6 later devices reach Aptima Combo 2 Assay (Panther System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230267NeuMoDx CT/NG Assay 2.0Neumodx Molecular, Inc.20230—
+1K202977Alinity m STI AssayAbbott Molecular, Inc.20221—
+1K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…Hologic, Inc.20202—
+2K222379Alinity m STI AssayAbbott Molecular, Inc.202301
+2K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, Inc.20201—
+3K220321Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris…Hologic, Inc.20220—