510(k) Report

Devices descending from K101365

11 later devices reach Elecsys CA 19-9 Calcheck 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122242Elecsys CA 15-3 II Calcheck 5Roche Diagnostics201210—
+2K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+2K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+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—