FDA Product Code NBC: Test, Natriuretic Peptide
Under FDA product code NBC, natriuretic peptide tests are cleared for the diagnosis and monitoring of heart failure.
These assays measure BNP (brain natriuretic peptide) or NT-proBNP levels in blood — biomarkers released by cardiac muscle cells in response to increased wall stress. Elevated levels indicate heart failure and correlate with disease severity, making them essential in emergency and outpatient cardiology.
NBC devices are Class II medical devices, regulated under 21 CFR 862.1117 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Biosite Incorporated, Dade Behring, Inc. and Bayer Healthcare, LLC.
47
Total
46
Cleared
153d
Avg days
2000
Since
Growing category -
5 submissions in the last 2 years
vs 3 in the prior period
Consistent review times:
158d avg (recent)
FDA 510(k) Cleared Test, Natriuretic Peptide Devices (Product Code NBC)
47 devices
Cleared
Oct 20, 2026
Access BNP II
Beckman Coulter, Inc.
Chemistry
85d
Cleared
Sep 21, 2026
Access NT-proBNP
Beckman Coulter, Inc.
Chemistry
90d
Cleared
Mar 24, 2026
Access BNP II
Beckman Coulter, Inc.
Chemistry
257d
Cleared
Feb 18, 2026
Alere NT-proBNP for Alinity i
Axis-Shield Diagnostics, Ltd.
Chemistry
97d
Cleared
Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
Axis-Shield Diagnostics, Ltd.
Chemistry
262d
Cleared
Apr 12, 2024
Access NT-proBNP
Beckman Coulter, Inc.
Chemistry
266d
Cleared
Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
Siemens Healthcare Diagnostics, Inc.
Chemistry
601d
Cleared
Jul 21, 2023
Elecsys proBNP II, Elecsys proBNP II STAT
Roche Diagnostics
Chemistry
228d
Cleared
Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
Roche Diagnostics
Chemistry
399d
Cleared
Nov 08, 2021
ST AIA-PACK BNP Assay
Tosoh Bioscience, Inc.
Chemistry
200d
Cleared
Oct 04, 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
Ortho-Clinical Diagnostics
Chemistry
504d
Cleared
Aug 24, 2020
ST AIA-PACK BNP
Fujirebio Diagnostics,Inc.
Chemistry
360d
Cleared
Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
Roche Diagnostics Corp.
Chemistry
160d
Cleared
Sep 22, 2008
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
Siemens Healthcare Diagnostics
Chemistry
11d
Cleared
Jul 21, 2008
RAMP NT-PROBNP ASSAY
Response Biomedical Corp.
Chemistry
591d
Cleared
Jun 06, 2008
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
Biosite Incorporated
Chemistry
126d
Cleared
May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
Siemens Healthcare Diagnostics, Inc.
Chemistry
74d
Cleared
Feb 29, 2008
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
bioMerieux, Inc.
Chemistry
120d
Cleared
Feb 05, 2008
PATHFAST NTPROBNP AND D-DIMER TESTS
Mitsubishi Kagaku Iatron
Chemistry
183d
Cleared
Feb 05, 2008
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
Roche Diagnostics
Chemistry
166d
Cleared
Aug 17, 2007
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
Dade Behring, Inc.
Chemistry
45d
Cleared
Aug 04, 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
Dade Behring, Inc.
Chemistry
36d
Cleared
Sep 11, 2006
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
Dade Behring, Inc.
Chemistry
80d
Cleared
Jul 21, 2006
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
I-Stat Corporation
Chemistry
210d
About Product Code NBC - Regulatory Context
510(k) Submission Activity
47 total 510(k) submissions under product code NBC since 2000, with 46 receiving FDA clearance (average review time: 153 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - NBC Product Code
FDA review times for NBC submissions have been consistent, averaging 158 days recently vs 153 days historically.
NBC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →