510(k) Report

Devices descending from K072437

20 later devices reach Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232164Access NT-proBNPBeckman Coulter, Inc.20241—
+1K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.20230—
+1K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20221—
+1K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics20210—
+1K092649Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Roche Diagnostics Corp.20105—
+1K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics200994
+2K262109Access NT-proBNPBeckman Coulter, Inc.20260—
+2K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.20260—
+2K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.20250—
+2K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20230—
+2K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+2K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics20160—
+3K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+3K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+3K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+3K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+3K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+3K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+4K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+5K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—