510(k) Report

Devices descending from DEN180069

3 later devices reach ZIKV Detect 2.0 IgM Capture ELISA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200506DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderChembio Diagnostic Systems20200—
+1K192046LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetDiaSorin, Inc.20190—
+1K191578ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50…Siemens Healthcare Diagnostics, Inc.20190—