510(k) Report

Devices descending from K093421

11 later devices reach Elecsys Testosterone II Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211685Elecsys Testosterone IIRoche Diagnostics20221—
+1K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+1K151529Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc.201601
+1K122793Liaison Testosterone; Liaison Testosterone Control SetDiaSorin, Inc.20131—
+1K120009Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)Abbott Laboratories20122—
+2K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems Limited20260—
+2K201908LIAISON Testosterone xtDiaSorin, Inc.20200—
+2K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+2K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—
+2K153577FREND Testosterone Test SystemNanoentek USA, Inc.20160—
+2K152155ARCHITECT 2nd Generation TestosteroneAbbott Laboratories20150—