510(k) Report

Devices descending from K082699

9 later devices reach Elecsys Troponin I and Troponin I Stat Test Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+2K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+2K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+2K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+2K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+2K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+2K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+3K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+4K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—