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 Dade Behring, Inc., Roche Diagnostics Corp. and Roche Diagnostics.
45
Total
44
Cleared
156d
Avg days
2000
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg
205d
recently vs 153d historically
FDA 510(k) Cleared Test, Natriuretic Peptide Devices (Product Code NBC)
45 devices
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
Feb 29, 2008
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
bioMerieux, Inc.
Chemistry
120d
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
Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
192d
Cleared
Feb 15, 2005
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
Dade Behring, Inc.
Chemistry
61d
Cleared
Nov 19, 2004
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
Dade Behring, Inc.
Chemistry
81d
Cleared
Jul 20, 2004
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
Dade Behring, Inc.
Chemistry
54d
Cleared
Nov 12, 2003
ELECSYS PROBNP IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
77d
Cleared
Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
112d
About Product Code NBC - Regulatory Context
510(k) Submission Activity
45 total 510(k) submissions under product code NBC since 2000, with 44 receiving FDA clearance (average review time: 156 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA 510(k) Review Time - NBC Product Code
Recent submissions under NBC have taken an average of 205 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.
NBC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →