510(k) Report

Devices descending from K101855

5 later devices reach Profast+ Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132237Prodesse Profast+ AssayGen-Probe Prodesse, Inc.20130—
+1K121003Abbott Plex-ID Flu AssayAbbott Laboratories20120—
+1K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc.201121
+2K163628Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV20170—
+2K131584Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc.20130—