510(k) Report

Devices descending from K100810

32 later devices reach Elecsys C-Peptide Calcheck 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142864ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI)…Siemens Healthcare Diagnostics, Inc.20141—
+1K103402Elecsys Dhea-S Calcheck 5Roche Diagnostics20113—
+1K103221Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics201010—
+1K102086Elecsys CA 125 II Calcheck 5Roche Diagnostics20102—
+1K101856Elecsys Cea Calcheck 5Roche Diagnostics20100—
+1K101365Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp.201011—
+2K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics20160—
+2K143534Elecsys CA-125 II assayRoche Professional Diagnostics20150—
+2K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+2K122242Elecsys CA 15-3 II Calcheck 5Roche Diagnostics201210—
+2K122141Ids-Isys Igf-I Calibration VerifiersImmunodiagnostic Systems, Ltd.20120—
+2K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+2K112104Elecsys N-Mid Osteocalcin Calcheck 5Roche Diagnostics20110—
+2K110613Elecsys Prolactin II Calcheck 5Roche Diagnostics20111—
+3K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+3K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+3K143194ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve…Siemens Healthcare Diagnostics, Inc.20140—
+3K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+4K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+4K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+4K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+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
+4K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+4K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+4K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+4K170938CalSet IGF-1Roche Diagnostics20170—
+4K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+5K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—
+5K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+6K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—