FDA product code NBC: Test, Natriuretic Peptide
NBC is the FDA product code for test, natriuretic peptide. It is a Class II device, regulated under 21 CFR 862.1117 and reviewed by the Clinical Chemistry panel. FDA has cleared 44 510(k) submissions under NBC, 7 in the last five years, from 18 different applicants. The average 510(k) review took 160 days (median 112); 235 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 22 recalls for NBC devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Natriuretic Peptide |
| Device class | Class II |
| Regulation | 21 CFR 862.1117 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for NBC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 360 |
| 2021 | 2 | 352 |
| 2022 | 1 | 399 |
| 2023 | 2 | 414 |
| 2024 | 1 | 266 |
| 2025 | 1 | 262 |
| 2026 | 2 | 177 |
Compare with all 510(k) review times · Search every NBC clearance
Top NBC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosite Incorporated | 8 | 2008-06-06 |
| Dade Behring, Inc. | 6 | 2007-08-17 |
| Bayer Healthcare, LLC | 5 | 2005-06-13 |
| Roche Diagnostics Corp. | 4 | 2010-02-04 |
| Axis-Shield Diagnostics, Ltd. | 3 | 2026-02-18 |
13 more applicants have NBC clearances. See the full list in Caduvo.
Most recent NBC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252169 | Beckman Coulter, Inc. | Access BNP II | 2026-03-24 | 257 |
| K253539 | Axis-Shield Diagnostics, Ltd. | Alere NT-proBNP for Alinity i | 2026-02-18 | 97 |
| K241176 | Axis-Shield Diagnostics, Ltd. | Alere NT-proBNP for Alinity i Reagent Kit | 2025-01-16 | 262 |
| K232164 | Beckman Coulter, Inc. | Access NT-proBNP | 2024-04-12 | 266 |
| K220265 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur® NT-proBNPII (PBNPII) | 2023-09-24 | 601 |
Recalls for NBC devices
22 product recalls in 18 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2020-10-01.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code NBC?
NBC is the FDA product code for test, natriuretic peptide. It is a Class II device, regulated under 21 CFR 862.1117 and reviewed by the Clinical Chemistry panel.
What device class is NBC?
Class II, regulation 21 CFR 862.1117. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBC?
Across 44 cleared submissions the average was 160 days from receipt to decision (median 112).
Which companies have the most NBC clearances?
Biosite Incorporated (8); Dade Behring, Inc. (6); Bayer Healthcare, LLC (5); Roche Diagnostics Corp. (4); Axis-Shield Diagnostics, Ltd. (3).
Have NBC devices been recalled?
Yes: 22 product recalls across 18 recall events; the most recent began 2020-10-01.
Next steps
- Run an FDA pathway report with predicate devices for product code NBC
- Run a recall and safety report across every NBC manufacturer
- Watch product code NBC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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