# K043476: Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 15, 2005 after 61 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN000010 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032646: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2003) Summary page 1.
- K022516: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2002) Summary page 1.

## Most influential descendants
- K060548: Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and Dilpak (2006), 1 descendant of its own
- K071834: Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm (2007), 0 descendants of its own

## Recalls of this device
- Apr 3, 2006 · Not classified · Z-0879-06: 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 fals
- Apr 3, 2006 · Not classified · Z-0885-06: 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 false

## Indications for use
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.

Source page: https://510kreport.com/device/K043476
Methodology: https://510kreport.com/methodology