Atlas FDA

NBC

45 FDA 510(k) clearances · Product code

112 daysmedian time to decision
360 days90th percentile
45clearances measured

FDA profile

Official device name
Test, Natriuretic Peptide
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1117
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2012: 23 · 2013: 13 · 2014: 70 · 2015: 43 · 2016: 31 · 2023: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access BNP II (K252169)Beckman Coulter, Inc.2026-03-24
Alere NT-proBNP for Alinity i (K253539)Axis-Shield Diagnostics, Ltd.2026-02-18
Alere NT-proBNP for Alinity i Reagent Kit (K241176)Axis-Shield Diagnostics, Ltd.2025-01-16
Access NT-proBNP (K232164)Beckman Coulter, Inc.2024-04-12
ADVIA Centaur® NT-proBNPII (PBNPII) (K220265)Siemens Healthcare Diagnostics, Inc.2023-09-24
Elecsys proBNP II, Elecsys proBNP II STAT (K223637)Roche Diagnostics2023-07-21
Elecsys proBNP II, Elecsys proBNP II STAT (K210546)Roche Diagnostics2022-03-31
ST AIA-PACK BNP Assay (K211199)Tosoh Bioscience, Inc.2021-11-08
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (K201312)Ortho Clinical Diagnostics2021-10-04
ST AIA-PACK BNP (K192380)Fujirebio Diagnostics,Inc.2020-08-24
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 (K092649)Roche Diagnostics Corp.2010-02-04
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 (K082645)Siemens Healthcare Diagnostics2008-09-22
RAMP NT-PROBNP ASSAY (K063662)Response Biomedical Corp.2008-07-21
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS (K080269)Biosite Incorporated2008-06-06
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA (K080578)Siemens Healthcare Diagnostics, Inc.2008-05-16
VIDAS NT-PROBNP ASSAY, MODEL: 30 449 (K073091)bioMerieux, Inc.2008-02-29
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET (K072437)Roche Diagnostics2008-02-05
PATHFAST NTPROBNP AND D-DIMER TESTS (K072189)Mitsubishi Kagaku Iatron2008-02-05
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM (K071834)Dade Behring, Inc.2007-08-17
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A (K071767)Dade Behring, Inc.2007-08-04
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061795)Dade Behring, Inc.2006-09-11
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) (K053597)I-Stat Corporation2006-07-21
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 (K060632)Ortho-Clinical Diagnostics, Inc.2006-06-06
ARCHITECT BNP ASSAY, MODEL 8K28 (K060964)Fujirebio Diagnostics,Inc.2006-05-25
STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 (K051596)Nanogen, Inc.2006-03-13
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 (K052789)Biosite Incorporated2006-01-23
ELECSYS PROBNP IMMUNOASSAY (K051382)Roche Diagnostics Corp.2005-12-05
TRIAGE BNP TEST, MODEL 98000XR (K051787)Biosite Incorporated2005-09-22
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K051265)Bayer Healthcare, LLC2005-06-13
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K043228)Bayer Healthcare, LLC2005-04-22
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT (K043476)Dade Behring, Inc.2005-02-15
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD (K042347)Dade Behring, Inc.2004-11-19
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 (K041417)Dade Behring, Inc.2004-07-20
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K040425)Bayer Healthcare, LLC2004-06-14
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST (K033606)Axis-Shield Diagnostics, Ltd.2004-01-30
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (K032235)Biosite Incorporated2004-01-28
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 (K033383)Biosite Incorporated2003-12-23
ELECSYS PROBNP IMMUNOASSAY (K032646)Roche Diagnostics Corp.2003-11-12
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K032525)Bayer Healthcare, LLC2003-09-09
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K031038)Bayer Healthcare, LLC2003-06-23
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL (K030286)Biosite Incorporated2003-02-21
ELECSYS PROBNP IMMUNOASSAY (K022516)Roche Diagnostics Corp.2002-11-19
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (K021317)Biosite Incorporated2002-07-01
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 (K010266)Biosite Incorporated2001-03-16
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (DEN000010)Biosite Incorporated2000-11-20

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Every clearance here is in the API, with alerts when new ones post.