# K220265: ADVIA Centaur® NT-proBNPII (PBNPII)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Sep 24, 2023 after 601 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931172 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset, Roche Diagnostics (2008) Summary page 4.

## Indications for use
The ADVIA Centaur® NT‑proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N‑terminal pro‑brain natriuretic peptide (NT‑proBNP) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system. In the Emergency Department (ED) and Outpatient (OP) populations, measurements of NT‑proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.

Source page: https://510kreport.com/device/K220265
Methodology: https://510kreport.com/methodology