510(k) · Cleared
ClearedElecsys Probnp Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NBC Test, Natriuretic Peptide
Cleared on Dec 5, 2005 as substantially equivalent to K032646 (Roche Diagnostics Corp., 2003) and 1 other predicate after a 192-day review. Its family tree reaches back 3 generations to 2000. 23 later devices descend from it.
- Decided
- Dec 5, 2005
- Review
- 192 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN000010 (2000). 23 later devices descend from it, 3 citing it directly.
- Root · 3 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 2 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- 1 generation backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- This deviceK051382 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2005
- Descendant · cites it directly · 20 of its ownK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- Descendant · 2 generations on · 9 of its ownK082699 Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · Recalled
- Descendant · 3 generations on · 8 of its ownK162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT…Roche Diagnostics · 2017
- Descendant · 2 generations on · 5 of its ownK092649 Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset…Roche Diagnostics Corp. · 2010
- Descendant · 4 generations on · 2 of its ownK191595 ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K072437Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008 · cites it directly20descendants
- K082699Elecsys Troponin I and Troponin I Stat Test SystemsRoche Diagnostics · 2009 · 2 generations on9descendants
- K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · 3 generations on8descendants
- K092649Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160…Roche Diagnostics Corp. · 2010 · 2 generations on5descendants
- K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division · 2019 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −2 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| −1 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K051382 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2005 | — |
| +1 | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| +2 | K082699 | Elecsys Troponin I and Troponin I Stat Test Systems | Roche Diagnostics | 2009 | 4 |
| +3 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… | Roche Diagnostics | 2017 | — |
| +2 | K092649 | Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models… | Roche Diagnostics Corp. | 2010 | — |
| +4 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K032646 | Elecsys Probnp ImmunoassaySummary page 1…is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Elecsys proBNP (K032646). 24 Elecsys® proBNP… | 2003 |
| * | K022516 | Elecsys Probnp ImmunoassaySummary page 4…tics Feature Elecsys proBNP Elecsys proBNP (add'l indication) (K022516) Precision E170 - Within run Same 0.9%CV @ 474 pg/mL… | 2002 |
What descends from it? (23)
See all 233 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K072437 (Roche Diagnostics, 2008) has gone furthest, with 20 descendants of its own.
- 7 other devices also cite its predicate K032646.
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 | — |
What is it indicated for?
For the in vitro quantitative determination of N-terminal proBrain natriuretic peptide in human serum and plasma.
Elecsys proBNP 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 or 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 the Roche Elecsys 1010, Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051382: Elecsys Probnp Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051382
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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