510(k) · Cleared
Recalled · 2006Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent
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 Feb 15, 2005 as substantially equivalent to K032646 (Roche Diagnostics Corp., 2003) and 1 other predicate after a 61-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 15, 2005
- Review
- 61 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN000010 (2000). 2 later devices descend from it, 2 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 deviceK043476 Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator…Dade Behring, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK060548 Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak…Dade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK071834 Stratus CS Acute Care NT-Probnp Testpak, Model CpbnpmDade Behring, Inc. · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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) | K043476 | Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak… | Dade Behring, Inc. | 2005 | — |
| +1 | K060548 | Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak… | Dade Behring, Inc. | 2006 | 2 |
| +1 | K071834 | Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm | Dade Behring, Inc. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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…A Reviewers' - 11/30/2000 Predicate Device(s): Roche Diagnostics Elecsys®)proBNP immunoassay and CalSet calibrator (K032646/K0225 16) Device Description(s): Method The Stratus® CS Acute Care"m NT-proBNP method is a two-site sandwich assay based upo… | 2003 |
| * | K022516 | Elecsys Probnp ImmunoassaySummary page 1…ers' - 11/30/2000 Predicate Device(s): Roche Diagnostics Elecsys®)proBNP immunoassay and CalSet calibrator (K032646/K0225 16) Device Description(s): Method The Stratus® CS Acute Care"m NT-proBNP method is a two-site sandwich assay based upon sol… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2006 | Not classified | Z-0879-06 | Other | Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the… |
| Apr 3, 2006 | Not classified | Z-0885-06 | Other | Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060548 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant 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 Stratus® CS Acute CareTM 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…
Read the full statement (121 words)
The Stratus® CS Acute CareTM 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.
The NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for calibration of the NT-proBNP method on the Stratus® CS analyzer.
The NT-proBNP Dilution Pak (DilPak) is an in vitro diagnostic product intended to be used for dilution of the NT-proBNP Method on the Stratus® CS analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043476 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043476: Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043476
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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