# K071834: Stratus CS Acute Care NT-Probnp Testpak, Model Cpbnpm

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 17, 2007 after 45 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: 5 generations back to DEN000010 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043476: Stratus CS Acute Care NT-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak Diluent, Dade Behring, Inc. (2005) Summary page 1.
- K060548: Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and Dilpak, Dade Behring, Inc. (2006) Summary page 1.

## Recalls of this device
- Nov 11, 2015 · Class II · Z-0610-2016: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- Apr 5, 2012 · Not classified · Z-1516-2012: 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 slop

## Indications for use
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.

Source page: https://510kreport.com/device/K071834
Methodology: https://510kreport.com/methodology