NBC · Test, Natriuretic Peptide
Clinical Chemistry · 21 CFR 862.1117 · Class 2
Overview
| Product Code | NBC |
|---|---|
| Device Name | Test, Natriuretic Peptide |
| Regulation | 21 CFR 862.1117 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.
Classification Rationale
Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
Special Controls
*Classification.* Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252169 | Access BNP II | Beckman Coulter, Inc. | Mar 24, 2026 | SESE |
| K253539 | Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. | Feb 18, 2026 | SESE |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. | Jan 16, 2025 | SESE |
| K232164 | Access NT-proBNP | Beckman Coulter, Inc. | Apr 12, 2024 | SESE |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | Siemens Healthcare Diagnostics, Inc. | Sep 24, 2023 | SESE |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | Jul 21, 2023 | SESE |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | Mar 31, 2022 | SESE |
| K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | Nov 8, 2021 | SESE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | Ortho Clinical Diagnostics | Oct 4, 2021 | SESE |
| K192380 | ST AIA-PACK BNP | Fujirebio Diagnostics,Inc. | Aug 24, 2020 | SESE |
| K092649 | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 | Roche Diagnostics Corp. | Feb 4, 2010 | SESE |
| K082645 | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 | Siemens Healthcare Diagnostics | Sep 22, 2008 | SESE |
| K063662 | RAMP NT-PROBNP ASSAY | Response Biomedical Corp. | Jul 21, 2008 | SESE |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | Biosite Incorporated | Jun 6, 2008 | SESE |
| K080578 | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | May 16, 2008 | SESE |
| K073091 | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 | bioMerieux, Inc. | Feb 29, 2008 | SESE |
| K072437 | ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET | Roche Diagnostics | Feb 5, 2008 | SESE |
| K072189 | PATHFAST NTPROBNP AND D-DIMER TESTS | Mitsubishi Kagaku Iatron | Feb 5, 2008 | SESE |
| K071834 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM | Dade Behring, Inc. | Aug 17, 2007 | SESE |
| K071767 | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A | Dade Behring, Inc. | Aug 4, 2007 | SESE |
Top Applicants
- Biosite Incorporated — 9 clearances
- Dade Behring, Inc. — 6 clearances
- Bayer Healthcare, LLC — 5 clearances
- Roche Diagnostics Corp. — 4 clearances
- Axis-Shield Diagnostics, Ltd. — 3 clearances
