510(k) · Cleared
Recalled · 2010Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge, Model RF623
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · NBC Test, Natriuretic Peptide
Cleared on Sep 22, 2008 as substantially equivalent to K080578 (Siemens Healthcare Diagnostics, Inc., 2008) after an 11-day review. Its family tree reaches back 5 generations to 2000. It has been recalled once.
- Decided
- Sep 22, 2008
- Review
- 11 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN000010 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 4 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- 3 generations backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- 2 generations backK061795 Dimension Vista PBNP Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 2006
- 1 generation backK080578 Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex…Siemens Healthcare Diagnostics, Inc. · 2008
- This deviceK082645 Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex…Siemens Healthcare Diagnostics · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −4 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| −3 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K082645 | Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent… | Siemens Healthcare Diagnostics | 2008 | — |
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? (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 |
|---|---|---|---|
| * | K080578 | Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge…Summary page 1…n Natriuretic Peptide (NTP) Flex® Reagent Cartridge (RF623) is substantially equivalent to the Dimension Vista® PBNP Flex® reagent cartridge (K6423A) cleared under K080578. G. Device Description: The EXL NTP method is a one-step sandwich chemiluminescent immunoassay based on LOCI® te… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2010 | Not classified | Z-0461-2011 | Other | Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K080578.
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?
The NTP 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® EXLTM integrated chemistry system with LOCI® Module. 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 failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082645: Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge, Model RF623.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082645
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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