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 Roche Diagnostics, Beckman Coulter, Inc. and Axis-Shield Diagnostics, Ltd..
FDA 510(k) Cleared Test, Natriuretic Peptide Devices (Product Code NBC)
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 Review Time
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 →