510(k) Report

Devices descending from K071146

24 later devices reach Vidas B.R.a.H.M.S. PCT Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242294DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab…Diasys Diagnostic Systems GmbH20250—
+1K160911Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc.201622—
+2K162827Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc.201721—
+3K220991IntelliSep testCytovale, Inc.20222—
+3K210254MeMed BVMeMed Diagnostics, Ltd.20213—
+3K192271Access PCT, Access PCT CalibratorsBeckman Coulter, Inc.201911
+3K181599Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationBeckman Coulter20192—
+3K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN…DiaSorin, Inc.20180—
+3K171338B R A H M S PCT sensitive KRYPTORBrahms GmbH20177—
+4K250912IntelliSep TestCytovale, Inc.20250—
+4K250513IntelliSep Test (CV-ICG-048)Cytovale, Inc.20250—
+4K222996Access PCTBeckman Coulter, Inc.20230—
+4K222332MeMed BVMeMed Diagnostics, Ltd.20231—
+4K220262Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.20220—
+4K213936LIAISON MeMed BV, LIAISON MeMed BV Control SetDiaSorin, Inc.20220—
+4K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter202011
+4K200236VITROS BRAHMS PCT Reagent Pack and CalibratorsOrtho Clinical Diagnostics20200—
+4K181002Atellica IM BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.20180—
+4K173927Elecsys BRAHMS PCTRoche Diagnostics20181—
+4K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT…Fujirebio Diagnostics,Inc.20170—
+4K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S…Fisher Diagnostics20170—
+5K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc.202402
+5K230944MeMed BVMeMed Diagnostics, Ltd.20230—
+5K192815Elecsys BRAHMS PCTRoche Diagnostics20200—