510(k) · Cleared
ClearedElecsys proBNP II, Elecsys proBNP II STAT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · NBC Test, Natriuretic Peptide
Cleared on Mar 31, 2022 as substantially equivalent to K072437 (Roche Diagnostics, 2008) and 1 other predicate after a 399-day review. Its family tree reaches back 7 generations to 1993. 1 later device descends from it.
- Decided
- Mar 31, 2022
- Review
- 399 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931172 (1993). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 6 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 5 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 4 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 3 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 2 generations backK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- 1 generation backK092649 Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset…Roche Diagnostics Corp. · 2010
- This deviceK210546 Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics · 2022
- Descendant · cites it directly · 0 of its ownK223637 Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics · 2023
Most influential descendants
Showing 1 of 1 · See all- K223637Elecsys proBNP II, Elecsys proBNP II STATRoche Diagnostics · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −6 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −3 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −2 | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| −1 | K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models… | Roche Diagnostics Corp. | 2010 | — |
| 0 (this device) | K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2022 | — |
| +1 | K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | Roche Diagnostics | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBC? 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 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetSummary page 7…est System Substantial The Elecsys proBNP II (updated assay) is substantially Equivalence equivalent to the Elecsys proBNP II (old assay, k072437) The Elecsys proBNP II (updated assay) STAT is substantially equivalent to the Elecsys proBNP II STA… | 2008 |
| * | K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Summary page 7…say, k072437) The Elecsys proBNP II (updated assay) STAT is substantially equivalent to the Elecsys proBNP II STAT (old assay, k092649) Intended Use Elecsys proBNP II STAT Immunoassay for the in vitro quantitative determination of… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K223637 (Roche Diagnostics, 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K072437.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Immunoassay for the in vitro quantitative determination of N terminal pro Brain natriuretic peptide in human serum and plasma. This assay is used as an aid in the diagnosis of individuals suspected of having heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in…
Read the full statement (196 words)
Immunoassay for the in vitro quantitative determination of N terminal pro Brain natriuretic peptide in human serum and plasma. This assay is used as an aid in the diagnosis of individuals suspected of having heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of Nterminal proBrain natriuretic peptide in human serum and plasma. This assay is used as an aid in the diagnosis of individuals suspected of having heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210546: Elecsys proBNP II, Elecsys proBNP II STAT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210546
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026