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 19, 2002 as substantially equivalent to DEN000010 (Biosite Incorporated, 2000) after a 112-day review. Its family tree reaches back 1 generation to 2000. 1 of the 48 devices in its family, counting itself, has a Class I recall. 46 later devices descend from it.
- Decided
- Nov 19, 2002
- Review
- 112 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN000010 (2000). 46 later devices descend from it, 9 citing it directly. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- This deviceK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- Descendant · cites it directly · 44 of its ownK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 23 of its ownK051382 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
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080269 Triage Cardioprofiler and Profiler S.O.B. Panels3 generations on · 2008
Most influential descendants
Showing 5 of 46 · See all- K032646Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003 · cites it directly44descendants
- K051382Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2005 · cites it directly23descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| 0 (this device) | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| +1 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 13.9 · 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 |
|---|---|---|---|
| * | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test Our reading of the summary gave K003475, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN000010, Triage B-Type Natriuretic Peptide (BNP) Test (Biosite Incorporated), granted Nov 20, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2000 |
What descends from it? (46)
See all 469 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032646 | Elecsys Probnp Immunoassay | 2003 | 44 |
| K051382 | Elecsys Probnp Immunoassay | 2005 | 23 |
| K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | 2008 | 20 |
| 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 |
| 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 |
| K073091 | Vidas NT-Probnp Assay, Model: 30 449 | 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 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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?
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. The Elecsys proBNP Immunoassay is intended for use as an aid in the diagnosis of individuals suspected of having congestive heart failure.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022516 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022516: Elecsys Probnp Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022516
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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