510(k) · Cleared
ClearedDimension Vista PBNP Flex Reagent Cartridge and Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · NBC Test, Natriuretic Peptide
Cleared on Sep 11, 2006 as substantially equivalent to K032646 (Roche Diagnostics Corp., 2003) and 1 other predicate after an 80-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it.
- Decided
- Sep 11, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN000010 (2000). 5 later devices descend from it, 1 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 deviceK061795 Dimension Vista PBNP Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK080578 Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex…Siemens Healthcare Diagnostics, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK113373 Dimension Vista Loci 9 Calibrator- Loci 9 CalSiemens Healthcare Diagnostics, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK130698 Dimension Vista Progesterone Calibrator (Prog Cal)Siemens Healthcare Diagnostics · 2013
- Descendant · 2 generations on · 0 of its ownK082680 Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model RC623Siemens Healthcare Diagnostics · 2008
- Descendant · 2 generations on · 0 of its ownK082645 Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex…Siemens Healthcare Diagnostics · 2008 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K080578Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge…Siemens Healthcare Diagnostics, Inc. · 2008 · cites it directly4descendants
- K113373Dimension Vista Loci 9 Calibrator- Loci 9 CalSiemens Healthcare Diagnostics, Inc. · 2011 · 2 generations on1descendant
- K130698Dimension Vista Progesterone Calibrator (Prog Cal)Siemens Healthcare Diagnostics · 2013 · 3 generations on0descendants
- K082680Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model RC623Siemens Healthcare Diagnostics · 2008 · 2 generations on0descendants
- K082645Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge…Siemens Healthcare Diagnostics · 2008 · 2 generations on0descendants
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) | K061795 | Dimension Vista PBNP Flex Reagent Cartridge and Calibrator | Dade Behring, Inc. | 2006 | — |
| +1 | K080578 | Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent… | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
| +2 | K113373 | Dimension Vista Loci 9 Calibrator- Loci 9 Cal | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
| +3 | K130698 | Dimension Vista Progesterone Calibrator (Prog Cal) | Siemens Healthcare Diagnostics | 2013 | — |
| +2 | K082680 | Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model RC623 | Siemens Healthcare Diagnostics | 2008 | — |
| +2 | K082645 | Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent… | Siemens Healthcare Diagnostics | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 13.9 · 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? (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…3. Identification of the Predicate Device * Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516). FDA Guidance Document(s): * "Class II Special Control Guidance Document for B-Type Natriureti… | 2003 |
| * | K022516 | Elecsys Probnp ImmunoassaySummary page 1…Identification of the Predicate Device * Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516). FDA Guidance Document(s): * "Class II Special Control Guidance Document for B-Type Natriuretic… | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080578 | Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge… | 2008 | 4 |
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 6 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K080578 (Siemens Healthcare Diagnostics, Inc., 2008) has gone furthest, with 4 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?
The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension VistaTM System. In individuals suspected of having congestive heart failure (CHF) measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart fhilure.
The Dimension VistaTM NT-proBNP (PBNP) calibrator is an in vitro diagnostic product for the calibration of the N-terminal pro-brain natriuretic peptide (PBNP) method on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061795 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061795: Dimension Vista PBNP Flex Reagent Cartridge and Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061795
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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