# K253539: Alere NT-proBNP for Alinity i

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Feb 18, 2026 after 97 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: 7 generations back to K931172 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092649: Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160, 04842472-190, Roche Diagnostics Corp. (2010) Summary page 5.

## Indications for use
The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system. In the emergency department, 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. The Alere NT-proBNP for Alinity i assay can also be used as an aid in 12-month risk stratification for prognosis of all-cause mortality, cardiac-related mortality, and heart-related hospitalization in patients presenting to the emergency department, diagnosed with new onset or worsening HF. The assay may further be used in the risk stratification of patients with acute coronary syndrome (ACS).

Source page: https://510kreport.com/device/K253539
Methodology: https://510kreport.com/methodology