510(k) Report

Devices descending from K162438

3 later devices reach Sofia Influenza A+B FIA on Sofia 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)20260—
+1K180288QuickVue Influenza A+BQuidel Corporation20181—
+2K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC20200—