510(k) · Cleared
Recalled · Class II · 2015Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm
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 Aug 17, 2007 as substantially equivalent to K043476 (Dade Behring, Inc., 2005) and 1 other predicate after a 45-day review. Its family tree reaches back 5 generations to 2000. It has been recalled 2 times.
- Decided
- Aug 17, 2007
- Review
- 45 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN000010 (2000). 6 ancestors in all. 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 backK043476 Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator…Dade Behring, Inc. · 2005 · Recalled
- 1 generation backK060548 Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak…Dade Behring, Inc. · 2006 · Recalled
- This deviceK071834 Stratus CS Acute Care NT-Probnp Testpak, Model CpbnpmDade Behring, Inc. · 2007
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 | K043476 | Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak… | Dade Behring, Inc. | 2005 | 2 |
| −1 | K060548 | Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak… | Dade Behring, Inc. | 2006 | 2 |
| 0 (this device) | K071834 | Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm | Dade Behring, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K043476 | Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak DiluentSummary page 1…rs" - 11/30/2000 Predicate Device(s): Dade Behring Stratus® CS Acute CareTm NT-proBNP (pBNP) TestPak (k043476/k060548) Device Description(s): Method The Stratus® CS Acute Care~ NT-proBNP method is a two-site sandwich assay based upon… | 2005 |
| * | K060548 | Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and DilpakSummary page 1…/30/2000 Predicate Device(s): Dade Behring Stratus® CS Acute CareTm NT-proBNP (pBNP) TestPak (k043476/k060548) Device Description(s): Method The Stratus® CS Acute Care~ NT-proBNP method is a two-site sandwich assay based upon solid… | 2006 |
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 |
|---|---|---|---|---|
| Nov 11, 2015 | Class II | Z-0610-2016 | Labeling design | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| Apr 5, 2012 | Not classified | Z-1516-2012 | Component design/selection | Firm has confirmed a low frequency of calibration failures due to slope errors that are not resolved with routine maintenance with the specific SCS Pro-BNP lots listed. This issue only causes the slope error failures but does not affect… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K043476.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. 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. This method is for use by trained health care professionals on the Stratus® CS Stat Fluorometric Analyzer in the clinical laboratory and point of care (POC) settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071834: Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071834
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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