Test, Natriuretic Peptide
FDA product code NBC · Class II (moderate risk) · 21 CFR 862.1117 · Clinical Chemistry
44510(k) clearances
0PMA approvals
20recalls
Manufacturers
- Biosite Incorporated 8
- Roche Diagnostics Corp. 7
- Dade Behring, Inc. 6
- Bayer Healthcare, LLC 5
- Axis-Shield Diagnostics, Ltd. 3
- Siemens Healthcare Diagnostics, Inc. 3
- Fujirebio Diagnostics,Inc. 2
- Ortho-Clinical Diagnostics 2
- Beckman Coulter Inc. 2
- Nanogen, Inc. 1
- I-Stat Corp. 1
- Mitsubishi Kagaku Iatron 1
- Biomerieux Inc 1
- Response Biomedical Corp. 1
- Tosoh Bioscience Inc 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252169 | Access BNP IINBC · Traditional | Beckman Coulter, Inc. | 03/24/2026SE |
| K253539 | Alere NT-proBNP for Alinity iNBC · Traditional | Axis-Shield Diagnostics, Ltd. | 02/18/2026SE |
| K241176 | Alere NT-proBNP for Alinity i Reagent KitNBC · Traditional | Axis-Shield Diagnostics, Ltd. | 01/16/2025SE |
| K232164 | Access NT-proBNPNBC · Traditional | Beckman Coulter, Inc. | 04/12/2024SE |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII)NBC · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/24/2023SE |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STATNBC · Traditional | Roche Diagnostics | 07/21/2023SE |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STATNBC · Traditional | Roche Diagnostics | 03/31/2022SE |
| K211199 | ST AIA-PACK BNP AssayNBC · Special | Tosoh Bioscience, Inc. | 11/08/2021SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | Ortho Clinical Diagnostics | 10/04/2021SE |
| K192380 | ST Aia-Pack BNPNBC · Traditional | Fujirebio Diagnostics,Inc. | 08/24/2020SE |
| K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…NBC · Special | Roche Diagnostics Corp. | 02/04/2010SE |
| K082645 | Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge…NBC · Special | Siemens Healthcare Diagnostics | 09/22/2008SE |
| K063662 | Ramp Nt-Probnp AssayNBC · Traditional | Response Biomedical Corp. | 07/21/2008SE |
| K080269 | Triage Cardioprofiler and Profiler S.O.B. PanelsNBC · Traditional | Biosite Incorporated | 06/06/2008SE |
| K080578 | Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge…NBC · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/16/2008SE |
| K073091 | Vidas Nt-Probnp Assay, Model: 30 449NBC · Traditional | bioMerieux, Inc. | 02/29/2008SE |
| K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetNBC · Traditional | Roche Diagnostics | 02/05/2008SE |
| K072189 | Pathfast Ntprobnp and D-Dimer TestsNBC · Traditional | Mitsubishi Kagaku Iatron | 02/05/2008SE |
| K071834 | Stratus CS Acute Care Nt-Probnp Testpak, Model CpbnpmNBC · Traditional | Dade Behring, Inc. | 08/17/2007SE |
| K071767 | Dimensions PBNP Flex Reagent Cartridge, Model RF423ANBC · Traditional | Dade Behring, Inc. | 08/04/2007SE |
| K061795 | Dimension Vista PBNP Flex Reagent Cartridge and CalibratorNBC · Traditional | Dade Behring, Inc. | 09/11/2006SE |
| K053597 | I-Stat B-Type Natriuretic Peptide (BNP)NBC · Traditional | I-Stat Corporation | 07/21/2006SE |
| K060632 | Vitros Immunodiagnostic Products NT Pro-Bnp Reagent Pack,Calibrators,Range VERIFIERS,680…NBC · Traditional | Ortho-Clinical Diagnostics, Inc. | 06/06/2006SE |
| K060964 | Architect BNP Assay, Model 8K28NBC · Traditional | Fujirebio Diagnostics,Inc. | 05/25/2006SE |
| K051596 | Statusfirst CHF (Congestive Heart Failure) Nt-Probnp, Model 20204NBC · Traditional | Nanogen, Inc. | 03/13/2006SE |
| K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200NBC · Traditional | Biosite Incorporated | 01/23/2006SE |
| K051382 | Elecsys Probnp ImmunoassayNBC · Traditional | Roche Diagnostics Corp. | 12/05/2005SE |
| K051787 | Triage BNP Test, Model 98000XRNBC · Traditional | Biosite Incorporated | 09/22/2005SE |
| K051265 | Advia Immuno Modular System (Ims) B-Type Natriuretic Peptide (BNP) AssayNBC · Traditional | Bayer Healthcare, LLC | 06/13/2005SE |
| K043228 | ACS:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysNBC · Traditional | Bayer Healthcare, LLC | 04/22/2005SE |
| K043476 | Stratus CS Acute Care Nt-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak DiluentNBC · Traditional | Dade Behring, Inc. | 02/15/2005SE |
| K042347 | Modification to Dimension Nt-Probnp Flex Reagent Cartridge MethodNBC · Traditional | Dade Behring, Inc. | 11/19/2004SE |
| K041417 | Dimension Nt-Probnp Flex Reagent Cartridge Method, Dimension PBNP Calibrator, Models…NBC · Traditional | Dade Behring, Inc. | 07/20/2004SE |
| K040425 | ACS:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysNBC · Traditional | Bayer Healthcare, LLC | 06/14/2004SE |
| K033606 | Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) TestNBC · Traditional | Axis-Shield Diagnostics, Ltd. | 01/30/2004SE |
| K032235 | Modification to Triage B-Type Natriuretic Peptide (BNP) TestNBC · Traditional | Biosite Incorporated | 01/28/2004SE |
| K033383 | Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200NBC · Traditional | Biosite Incorporated | 12/23/2003SE |
| K032646 | Elecsys Probnp ImmunoassayNBC · Traditional | Roche Diagnostics Corp. | 11/12/2003SE |
| K032525 | Bayer Advia Centaur Automated Chemiluminescence AnalyzerNBC · Special | Bayer Healthcare, LLC | 09/09/2003SE |
| K031038 | Advia Centaur B-Type Natriuretic Peptide (BNP) AssayNBC · Traditional | Bayer Healthcare, LLC | 06/23/2003SE |
| K030286 | Triage Cardio Profiler/Triage Cardiac PanelNBC · Special | Biosite Incorporated | 02/21/2003SE |
| K022516 | Elecsys Probnp ImmunoassayNBC · Traditional | Roche Diagnostics Corp. | 11/19/2002SE |
| K021317 | Triage B-Type Natriuretic Peptide (BNP) TestNBC · Traditional | Biosite Incorporated | 07/01/2002SE |
| K010266 | Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000NBC · Traditional | Biosite Incorporated | 03/16/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0297-2021 Class II | The Quidel Triage BNP CalibratorsProduct compromised during shipment. | Medline Industries Inc | 10/01/2020Terminated |
| Z-0689-2019 Class II | VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use…The firm is extending their previous July 2018 recall to include additional product codes. Biased results… | Ortho-Clinical Diagnostics | 11/01/2018Open, Classified |
| Z-3186-2018 Class II | PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST NTproBNP is a product for in-vitro…A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage… | Polymedco, Inc.,/Polymedco Cancer… | 04/30/2018Terminated |
| Z-2053-2018 Class II | ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests)…In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution… | Siemens Healthcare Diagnostics, Inc. | 12/18/2017Open, Classified |
| Z-1765-2017 Class II | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD ---…Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots… | Ortho-Clinical Diagnostics | 03/07/2017Terminated |
| Z-2779-2016 Class III | VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test…Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. | Biomerieux France Chemin De L'Or | 04/15/2016Terminated |
| Z-0610-2016 Class II | Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative…Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | Siemens Healthcare Diagnostics Inc | 11/11/2015Terminated |
| Z-0229-2015 Class III | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of…Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur… | Siemens Healthcare Diagnostics, Inc | 10/06/2014Terminated |
| Z-2150-2014 Class II | SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in…Complaints of failed calibration. | Siemens Healthcare Diagnostics, Inc | 06/23/2014Terminated |
| Z-2149-2014 Class II | SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in…Complaints of failed calibration. | Siemens Healthcare Diagnostics, Inc | 06/23/2014Terminated |
| Z-1928-2014 Class III | Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay…Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of… | Alere San Diego, Inc. | 05/30/2014Terminated |
| Z-1540-2014 Class II | Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems…These lots may not recover within range when tested using certain commercially available controls. | Alere San Diego, Inc. | 03/20/2014Terminated |
| Z-0506-2013 Class II | Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | Siemens Healthcare Diagnostics, Inc | 11/14/2012Terminated |
| Z-2313-2012 Class II | Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA…Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA… | Siemens Healthcare Diagnostics, Inc | 07/25/2012Terminated |
| Z-1931-2012 Class I | Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and…Certain lots of the affected products may have significantly decreased precision relative to the package… | Alere San Diego, Inc. | 05/22/2012Terminated |
| Z-1929-2012 Class I | Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of…Certain lots of the affected products may have significantly decreased precision relative to the package… | Alere San Diego, Inc. | 05/22/2012Terminated |
| Z-1928-2012 Class I | Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of…Certain lots of the affected products may have significantly decreased precision relative to the package… | Alere San Diego, Inc. | 05/22/2012Terminated |
| Z-1516-2012 | Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS…Firm has confirmed a low frequency of calibration failures due to slope errors that are not resolved with… | Siemens Healthcare Diagnostics, Inc. | 04/05/2012Terminated |
| Z-2170-2012 Class II | i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro…The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric… | Abbott Point Of Care Inc. | 02/01/2012Terminated |
| Z-0461-2011 | The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic…Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high… | Siemens Healthcare Diagnostics, Inc. | 04/12/2010Terminated |