510(k) Report

Devices descending from K032089

41 later devices reach Roche Diagnostics Elecsys Precicontrol Cardiac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics200820—
+1K033937Elecsys Precicontrol MultianalyteRoche Diagnostics Corp.200419—
+2K232164Access NT-proBNPBeckman Coulter, Inc.20241—
+2K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.20230—
+2K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20221—
+2K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics20210—
+2K102157Elecsys Precicontrol MultimarkerRoche Diagnostics20109—
+2K092649Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Roche Diagnostics Corp.20105—
+2K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics200994
+2K051687Elecsys Precicontrol UniversalRoche Diagnostics Corp.20052—
+2K051517Elecsys Precicontrol AnemiaRoche Diagnostics Corp.20058—
+3K262109Access NT-proBNPBeckman Coulter, Inc.20260—
+3K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.20260—
+3K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.20250—
+3K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20230—
+3K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+3K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics20160—
+3K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+3K090541Elecsys Precicontrol UniversalRoche Diagnostics20091—
+3K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+4K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+4K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+4K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+4K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+4K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+4K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+4K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+4K141426Elecsys Folate IiiRoche Diagnostics20140—
+4K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+4K130469Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…DiaSorin, Inc.20130—
+4K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+4K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics20111—
+5K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+5K233060Elecsys Folate IIIRoche Diagnostics20240—
+5K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+5K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+5K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+5K170938CalSet IGF-1Roche Diagnostics20170—
+5K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+6K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—
+6K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—