510(k) Report

Devices descending from K031698

44 later devices reach Elecys SHBG Calcheck through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111349Elecsys SHBG Calcheck 5Roche Diagnostics20110—
+1K040157Elecsys C-Peptide CalcheckRoche Diagnostics Corp.200442—
+2K100810Elecsys C-Peptide Calcheck 5Roche Diagnostics201032—
+2K091601Elecys Anti-CCP CalcheckRoche Diagnostics Corp.20091—
+2K090311Elecsys Rubella Igg CalcheckRoche Diagnostics20091—
+2K083655Elecsys Toxo Igg CalcheckRoche Diagnostics20091—
+2K080643Elecsys Anti-TSHR CalcheckRoche Diagnostics20081—
+2K051185Elecsys CA 19-9 CalcheckRoche Diagnostics Corp.200512—
+3K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.201601
+3K142864ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI)…Siemens Healthcare Diagnostics, Inc.20141—
+3K121576Immulite 2000 Anti-CCP Igg AssaySiemens Healthcare Diagnostics, Inc.20130—
+3K103402Elecsys Dhea-S Calcheck 5Roche Diagnostics20113—
+3K103221Elecys HGH Calset, Elecsys HGH Calcheck 5Roche Diagnostics201010—
+3K102086Elecsys CA 125 II Calcheck 5Roche Diagnostics20102—
+3K101365Elecsys CA 19-9 Calcheck 5Roche Diagnostics Corp.201011—
+3K101856Elecsys Cea Calcheck 5Roche Diagnostics20100—
+3K092888Elecsys Toxo Igg Calcheck 5Roche Diagnostics Corp.20090—
+3K092585Elecsys Rubella Igga Calcheck 5Roche Diagnostics20090—
+4K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics20160—
+4K143534Elecsys CA-125 II assayRoche Professional Diagnostics20150—
+4K132739Immulite 2000 Afp, BR-MA, and OM-MA Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+4K122242Elecsys CA 15-3 II Calcheck 5Roche Diagnostics201210—
+4K122141Ids-Isys Igf-I Calibration VerifiersImmunodiagnostic Systems, Ltd.20120—
+4K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+4K112104Elecsys N-Mid Osteocalcin Calcheck 5Roche Diagnostics20110—
+4K110613Elecsys Prolactin II Calcheck 5Roche Diagnostics20111—
+5K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+5K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+5K143194ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve…Siemens Healthcare Diagnostics, Inc.20140—
+5K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+6K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+6K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+6K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+6K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+6K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+6K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+6K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+6K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+6K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+6K170938CalSet IGF-1Roche Diagnostics20170—
+6K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+7K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—
+7K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+8K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—