510(k) Report

Devices descending from K983492

51 later devices reach Boehringer Mannheim Elecsys Presicontrol Cardiac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031990Elecsys Precicontrol Troponin TRoche Diagnostics Corp.20038—
+1K032089Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp.200341—
+2K092322Elecsys Rubella Igm ImmunoassayRoche Diagnostics20102—
+2K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics200820—
+2K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp.20064—
+2K033937Elecsys Precicontrol MultianalyteRoche Diagnostics Corp.200419—
+3K232164Access NT-proBNPBeckman Coulter, Inc.20241—
+3K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.20230—
+3K223867Ids Acth IIImmunodiagnostic Systems Limited20230—
+3K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20221—
+3K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics20210—
+3K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics20141—
+3K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20130—
+3K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc.201112
+3K102157Elecsys Precicontrol MultimarkerRoche Diagnostics20109—
+3K092649Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Roche Diagnostics Corp.20105—
+3K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics200994
+3K051687Elecsys Precicontrol UniversalRoche Diagnostics Corp.20052—
+3K051517Elecsys Precicontrol AnemiaRoche Diagnostics Corp.20058—
+4K262109Access NT-proBNPBeckman Coulter, Inc.20260—
+4K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.20260—
+4K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.20250—
+4K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20230—
+4K163569Elecsys CMV IgMRoche Diagnostics201702
+4K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+4K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics20160—
+4K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc.20140—
+4K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+4K090541Elecsys Precicontrol UniversalRoche Diagnostics20091—
+4K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+5K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+5K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+5K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+5K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+5K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+5K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+5K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+5K141426Elecsys Folate IiiRoche Diagnostics20140—
+5K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+5K130469Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…DiaSorin, Inc.20130—
+5K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+5K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics20111—
+6K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+6K233060Elecsys Folate IIIRoche Diagnostics20240—
+6K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+6K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+6K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+6K170938CalSet IGF-1Roche Diagnostics20170—
+6K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+7K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—
+7K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—