510(k) Report

Devices descending from DEN000010

47 later devices reach Triage B-Type Natriuretic Peptide (BNP) Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093758BGM Galectin -3Bg Medicine, Inc.20102—
+1K022516Elecsys Probnp ImmunoassayRoche Diagnostics Corp.200246—
+2K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc.20140—
+2K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag201101
+2K063662Ramp NT-Probnp AssayResponse Biomedical Corp.20080—
+2K073091Vidas NT-Probnp Assay, Model: 30 449bioMerieux, Inc.200801
+2K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics200820—
+2K061795Dimension Vista PBNP Flex Reagent Cartridge and CalibratorDade Behring, Inc.20065—
+2K051382Elecsys Probnp ImmunoassayRoche Diagnostics Corp.200523—
+2K043476Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak DiluentDade Behring, Inc.200522
+2K042347Modification to Dimension NT-Probnp Flex Reagent Cartridge MethodDade Behring, Inc.20041—
+2K041417Dimension NT-Probnp Flex Reagent Cartridge Method, Dimension PBNP Calibrator, Models…Dade Behring, Inc.20041—
+2K032646Elecsys Probnp ImmunoassayRoche Diagnostics Corp.200344—
+3K232164Access NT-proBNPBeckman Coulter, Inc.20241—
+3K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc.20230—
+3K210546Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20221—
+3K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics20210—
+3K092649Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Roche Diagnostics Corp.20105—
+3K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics200994
+3K080578Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge…Siemens Healthcare Diagnostics, Inc.20084—
+3K071834Stratus CS Acute Care NT-Probnp Testpak, Model CpbnpmDade Behring, Inc.200702
+3K071767Dimensions PBNP Flex Reagent Cartridge, Model RF423ADade Behring, Inc.20070—
+3K060632Vitros Immunodiagnostic Products NT Pro-BNP Reagent Pack,Calibrators,Range Verifiers,680…Ortho-Clinical Diagnostics, Inc.200602
+3K060548Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and DilpakDade Behring, Inc.200612
+3K051596Statusfirst CHF (Congestive Heart Failure) NT-Probnp, Model 20204Nanogen, Inc.20061—
+3K051787Triage BNP Test, Model 98000XRBiosite Incorporated20056—
+4K262109Access NT-proBNPBeckman Coulter, Inc.20260—
+4K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.20260—
+4K241176Alere NT-proBNP for Alinity i Reagent KitAxis-Shield Diagnostics, Ltd.20250—
+4K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics20230—
+4K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics20178—
+4K153301Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics20160—
+4K113373Dimension Vista Loci 9 Calibrator- Loci 9 CalSiemens Healthcare Diagnostics, Inc.20111—
+4K082680Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model RC623Siemens Healthcare Diagnostics20080—
+4K082645Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge…Siemens Healthcare Diagnostics200801
+4K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated20083Class I
+4K052789Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated200641
+5K252169Access BNP IIBeckman Coulter, Inc.20260—
+5K201441Elecsys Troponin T Gen 5Roche Diagnostics20210—
+5K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20192—
+5K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+5K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.201901
+5K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+5K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.20180—
+5K130698Dimension Vista Progesterone Calibrator (Prog Cal)Siemens Healthcare Diagnostics20130—
+6K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20221—
+7K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division20230—