510(k) Report

Devices descending from K051382

23 later devices reach Elecsys Probnp Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063662Ramp NT-Probnp AssayResponse Biomedical Corp.20080—
+1K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics200820—
+1K060632Vitros Immunodiagnostic Products NT Pro-BNP Reagent Pack,Calibrators,Range Verifiers,680…Ortho-Clinical Diagnostics, Inc.200602
+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—
+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
+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—
+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—
+5K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+6K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—