510(k) Report

Devices descending from K014233

10 later devices reach Captiam Syphilis-G Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061247Diasorin Liaison Treponema AssayDiaSorin, Inc.20069—
+2K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set…Bio-Rad Laboratories201705
+2K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP…Abbott Laboratories20161—
+2K091361Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics200952
+3K241427Access SyphilisBeckman Coulter, Inc.20240—
+3K160910Elecsys SyphilisRoche Diagnostics20162—
+3K112343Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc.201212
+4K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics20240—
+4K211302Elecsys SyphilisRoche Diagnostics20211—
+4K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc.20160—