NBC · Class II · 21 CFR 862.1117

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.

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
1–24 of 45
Cleared Mar 24, 2026
Access BNP II
K252169
Beckman Coulter, Inc.
Chemistry · 257d
Cleared Feb 18, 2026
Alere NT-proBNP for Alinity i
K253539
Axis-Shield Diagnostics, Ltd.
Chemistry · 97d
Cleared Jan 16, 2025
Alere NT-proBNP for Alinity i Reagent Kit
K241176
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
Cleared Apr 12, 2024
Access NT-proBNP
K232164
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
K220265
Siemens Healthcare Diagnostics, Inc.
Chemistry · 601d
Cleared Jul 21, 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K223637
Roche Diagnostics
Chemistry · 228d
Cleared Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
K210546
Roche Diagnostics
Chemistry · 399d
Cleared Nov 08, 2021
ST AIA-PACK BNP Assay
K211199
Tosoh Bioscience, Inc.
Chemistry · 200d
Cleared Oct 04, 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
K201312
Ortho-Clinical Diagnostics
Chemistry · 504d
Cleared Aug 24, 2020
ST AIA-PACK BNP
K192380
Fujirebio Diagnostics,Inc.
Chemistry · 360d
Cleared Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
K092649
Roche Diagnostics Corp.
Chemistry · 160d
Cleared Sep 22, 2008
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
K082645
Siemens Healthcare Diagnostics
Chemistry · 11d
Cleared Jun 06, 2008
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
K080269
Biosite Incorporated
Chemistry · 126d
Cleared May 16, 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
K080578
Siemens Healthcare Diagnostics, Inc.
Chemistry · 74d
Cleared Feb 29, 2008
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
K073091
bioMerieux, Inc.
Chemistry · 120d
Cleared Feb 05, 2008
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
K072437
Roche Diagnostics
Chemistry · 166d
Cleared Aug 17, 2007
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
K071834
Dade Behring, Inc.
Chemistry · 45d
Cleared Aug 04, 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
K071767
Dade Behring, Inc.
Chemistry · 36d
Cleared Sep 11, 2006
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795
Dade Behring, Inc.
Chemistry · 80d
Cleared Jun 06, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
K060632
Ortho-Clinical Diagnostics, Inc.
Chemistry · 89d
Cleared May 25, 2006
ARCHITECT BNP ASSAY, MODEL 8K28
K060964
Fujirebio Diagnostics,Inc.
Chemistry · 48d
Cleared Jan 23, 2006
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
K052789
Biosite Incorporated
Chemistry · 112d
Cleared Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
K051382
Roche Diagnostics Corp.
Chemistry · 192d
Cleared Sep 22, 2005
TRIAGE BNP TEST, MODEL 98000XR
K051787
Biosite Incorporated
Chemistry · 83d

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 →