510(k) · Cleared
ClearedElecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset
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 Feb 5, 2008 as substantially equivalent to K051382 (Roche Diagnostics Corp., 2005) and 2 other predicates after a 166-day review. Its family tree reaches back 5 generations to 1993. 20 later devices descend from it.
- Decided
- Feb 5, 2008
- Review
- 166 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K931172 (1993). 10 ancestors in all. 20 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 4 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 3 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 2 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 1 generation backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- This deviceK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- Descendant · cites it directly · 9 of its ownK082699 Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 8 of its ownK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
- Descendant · cites it directly · 5 of its ownK092649 Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset…Roche Diagnostics Corp. · 2010
- Descendant · 3 generations on · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
- Descendant · cites it directly · 1 of its ownK232164 Access NT-proBNPBeckman Coulter, Inc. · 2024
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · cites it directly9descendants
- K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · 2 generations on8descendants
- K092649Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Roche Diagnostics Corp. · 2010 · cites it directly5descendants
- K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · 3 generations on2descendants
- K232164Access NT-proBNPBeckman Coulter, Inc. · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −4 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −2 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| +1 | K082699 | Elecsys Troponin I and Troponin I Stat Test Systems | Roche Diagnostics | 2009 | 4 |
| +2 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… | Roche Diagnostics | 2017 | — |
| +1 | K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models… | Roche Diagnostics Corp. | 2010 | — |
| +3 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019 | — |
| +1 | K232164 | Access NT-proBNP | Beckman Coulter, Inc. | 2024 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K051382 | Elecsys Probnp ImmunoassaySummary page 3…(K022516). Device The following table compares the Elecsys proBNP II test system with the Comparison - predicate device (K051382). Immunoassay I ___________.. . TmmU. .o.ssay,:… | 2005 |
| * | K032089 | Roche Diagnostics Elecsys Precicontrol CardiacSummary page 3…Immunoassay (KO51382). 2.) Elecsys PreciControl Cardiac II is equivalent to Elecsys PreciControl Cardiac (K032089). 3.) Elecsys proBNP Ii CalSet is equivalent to Elecsys proBNP CalSet (K022… | 2003 |
| * | K022516 | Elecsys Probnp ImmunoassaySummary page 3…Cardiac (K032089). 3.) Elecsys proBNP Ii CalSet is equivalent to Elecsys proBNP CalSet (K022516). Device The following table compares the Elecsys proBNP II test system with the Comparison - pre… | 2002 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082699 | Elecsys Troponin I and Troponin I Stat Test Systems | 2009 | 9 |
| K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160… | 2010 | 5 |
| K232164 | Access NT-proBNP | 2024 | 1 |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | 2022 | 1 |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | 2023 | 0 |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | 2021 | 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 15 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K082699 (Roche Diagnostics, 2009) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K051382.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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. Elecsys proBNP II assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure. The test may also serve as an aid in the assessment of increased risk of…
Read the full statement (147 words)
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. Elecsys proBNP II assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive 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 Elecsys and cobas e immunoassay analyzers.
The Elecsys PreciControl Cardiac II is used for quality control of specified immunoassays on the Elecsys and cobas e immunoassay analyzers.
The Elecsys proBNP II CalSet is used for calibrating the quantitative Elecsys proBNP II assay on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072437
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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