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 Nov 12, 2003 as substantially equivalent to K022516 (Roche Diagnostics Corp., 2002) after a 77-day review. Its family tree reaches back 2 generations to 2000. 1 of the 47 devices in its family, counting itself, has a Class I recall. 44 later devices descend from it.
- Decided
- Nov 12, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN000010 (2000). 44 later devices descend from it, 8 citing it directly. 1 of the 47 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 1 generation backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- This deviceK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 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
- Descendant · 4 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 · 6 of its ownK051787 Triage BNP Test, Model 98000XRBiosite Incorporated · 2005
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080269 Triage Cardioprofiler and Profiler S.O.B. Panels2 generations on · 2008
Most influential descendants
Showing 5 of 44 · See all- K051382Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2005 · cites it directly23descendants
- 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
- K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys…Roche Diagnostics · 2017 · 4 generations on8descendants
- K051787Triage BNP Test, Model 98000XRBiosite Incorporated · 2005 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −1 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| 0 (this device) | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| +1 | 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 |
| +4 | K162895 | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet… | Roche Diagnostics | 2017 | — |
| +1 | K051787 | Triage BNP Test, Model 98000XR | Biosite Incorporated | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 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 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.
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 13.8 · 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? (1)
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 |
|---|---|---|---|
| * | K022516 | Elecsys Probnp ImmunoassaySummary page 3…ys proBNP Immunoassay with the predicate devices. equivalence — comparison Table 3 - Comparison to Predicate Device Feature Elecsys proBNP Elecsys proBNP Triage BNP o« (K022516) (add’l indication) (K021317) Intgnded Use Immunoassay for the in vitro Imunnoassay for the in vitro The Triage BNP test is inten… | 2002 |
| † | K021317 | Triage B-Type Natriuretic Peptide (BNP) Test | 2002 |
What descends from it? (44)
See all 448 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051382 | Elecsys Probnp Immunoassay | 2005 | 23 |
| K051787 | Triage BNP Test, Model 98000XR | 2005 | 6 |
| K061795 | Dimension Vista PBNP Flex Reagent Cartridge and Calibrator | 2006 | 5 |
| K043476 | Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent | 2005 | 2 |
| K051596 | Statusfirst CHF (Congestive Heart Failure) NT-Probnp, Model 20204 | 2006 | 1 |
| K042347 | Modification to Dimension NT-Probnp Flex Reagent Cartridge Method | 2004 | 1 |
| K041417 | Dimension NT-Probnp Flex Reagent Cartridge Method, Dimension PBNP Calibrator, Models… | 2004 | 1 |
| K063662 | Ramp NT-Probnp Assay | 2008 | 0 |
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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051382 (Roche Diagnostics Corp., 2005) has gone furthest, with 23 descendants of its own.
- 8 other devices also cite its predicate K022516.
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 and congestive heart failure.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010, Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K032646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032646: 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/K032646
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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