# K223637: Elecsys proBNP II, Elecsys proBNP II STAT

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 21, 2023 after 228 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: 8 generations back to K931172 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210546: Elecsys proBNP II, Elecsys proBNP II STAT, Roche Diagnostics (2022) Summary page 4.

## Indications for use
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. This assay is used as an aid in the diagnosis of individuals suspected of having heart failure. It can be used as an aid in the diagnosis of acute decompensated heart failure (ADHF) in patients presenting with signs and symptoms of ADHF to the emergency department (ED). The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K223637
Methodology: https://510kreport.com/methodology