510(k) Report

Devices descending from K931172

58 later devices reach Imx (R) Stat CK-MB through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961501Elecsys CK-MBBoehringer Mannheim Corp.199657—
+2K974421Elecsys CK-MB StatBoehringer Mannheim Corp.19973—
+2K962575Elecsys Precicontrol CardiacBoehringer Mannheim Corp.199652—
+3K022654Modification to Elecsys CK-MB Stat, Elecsys CK-MBRoche Diagnostics Corp.20022—
+3K983492Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp.199851—
+4K132571Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB ImmunoassayRoche Diagnostics20131—
+4K031990Elecsys Precicontrol Troponin TRoche Diagnostics Corp.20038—
+4K032089Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp.200341—
+5K140404Elecsys CK-MB Stat ImmunoassayRoche Diagnostics20140—
+5K092322Elecsys Rubella Igm ImmunoassayRoche Diagnostics20102—
+5K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics200820—
+5K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp.20064—
+5K033937Elecsys Precicontrol MultianalyteRoche Diagnostics Corp.200419—
+6K232164Access NT-proBNPBeckman Coulter, Inc.20241—
+6K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.20230—
+6K223867Ids Acth IIImmunodiagnostic Systems Limited20230—
+6K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20221—
+6K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics20210—
+6K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics20141—
+6K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20130—
+6K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc.201112
+6K102157Elecsys Precicontrol MultimarkerRoche Diagnostics20109—
+6K092649Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Roche Diagnostics Corp.20105—
+6K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics200994
+6K051687Elecsys Precicontrol UniversalRoche Diagnostics Corp.20052—
+6K051517Elecsys Precicontrol AnemiaRoche Diagnostics Corp.20058—
+7K262109Access NT-proBNPBeckman Coulter, Inc.20260—
+7K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.20260—
+7K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.20250—
+7K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20230—
+7K163569Elecsys CMV IgMRoche Diagnostics201702
+7K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+7K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics20160—
+7K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc.20140—
+7K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+7K090541Elecsys Precicontrol UniversalRoche Diagnostics20091—
+7K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+8K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+8K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+8K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+8K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+8K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+8K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+8K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+8K141426Elecsys Folate IiiRoche Diagnostics20140—
+8K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+8K130469Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…DiaSorin, Inc.20130—
+8K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+8K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics20111—
+9K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+9K233060Elecsys Folate IIIRoche Diagnostics20240—
+9K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+9K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+9K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+9K170938CalSet IGF-1Roche Diagnostics20170—
+9K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+10K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—
+10K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—