De Novo · Granted
GrantedTriage B-Type Natriuretic Peptide (BNP) Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · NBC Test, Natriuretic Peptide
Granted on Nov 20, 2000 as a new device type through De Novo after a 5-day review. 1 of the 48 devices in its family, counting itself, has a Class I recall. 47 later devices descend from it.
- Decided
- Nov 20, 2000
- Review
- 5 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
47 later devices descend from it, 2 citing it directly. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- This deviceDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- Descendant · cites it directly · 46 of its ownK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- Descendant · 2 generations on · 44 of its ownK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 23 of its ownK051382 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2005
- Descendant · 2 generations on · 20 of its ownK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- Descendant · 3 generations on · 9 of its ownK082699 Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · Recalled
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080269 Triage Cardioprofiler and Profiler S.O.B. Panels4 generations on · 2008
Most influential descendants
Showing 5 of 47 · See all- K022516Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002 · cites it directly46descendants
- K032646Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003 · 2 generations on44descendants
- K051382Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2005 · 2 generations on23descendants
- K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008 · 2 generations on20descendants
- K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| +1 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| +2 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| +2 | K051382 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2005 | — |
| +2 | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| +3 | K082699 | Elecsys Troponin I and Troponin I Stat Test Systems | Roche Diagnostics | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 7 | 1 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBC device
- #1 K262109 Access NT-proBNPscore 13.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (47)
See all 472 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K022516 (Roche Diagnostics Corp., 2002) has gone furthest, with 46 descendants of its own.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBC
126in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBC
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NBC
17in 2025
MAUDE reports naming product code NBC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 17 |
| 2008 | 7 | 126 | 0 | 15 |
| 2009 | 0 | — | 0 | 35 |
| 2010 | 1 | — | 1 | 61 |
| 2011 | 0 | — | 0 | 53 |
| 2012 | 0 | — | 2 | 23 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 1 | 70 |
| 2015 | 0 | — | 1 | 43 |
| 2016 | 0 | — | 0 | 31 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 1 | 6 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 26 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 4 | 94 | 0 | — |
https://510kreport.com/device/DEN000010 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN000010: Triage B-Type Natriuretic Peptide (BNP) Test.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN000010
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026