510(k) Report

Devices descending from K964889

15 later devices reach Elecsys Testosterone Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093421Elecsys Testosterone II ImmunoassayRoche Diagnostics Corp.201011—
+1K041866Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)Axis-Shield Diagnostics, Ltd.20040—
+1K021972Fastpack Total Testosterone ImmunoassayQualigen, Inc.200211
+2K211685Elecsys Testosterone IIRoche Diagnostics20221—
+2K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+2K151529Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc.201601
+2K122793Liaison Testosterone; Liaison Testosterone Control SetDiaSorin, Inc.20131—
+2K120009Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)Abbott Laboratories20122—
+2K101388Fastpack Testo ImmunoassayQualigen, Inc.20110—
+3K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems Limited20260—
+3K201908LIAISON Testosterone xtDiaSorin, Inc.20200—
+3K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+3K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—
+3K153577FREND Testosterone Test SystemNanoentek USA, Inc.20160—
+3K152155ARCHITECT 2nd Generation TestosteroneAbbott Laboratories20150—