# K262109: Access NT-proBNP

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 21, 2026 after 90 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)
- K232164: Access NT-proBNP, Beckman Coulter, Inc. (2024) Summary page 5.

## Indications for use
The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-terminal pro B-type natriuretic peptide levels in human serum and plasma using the automated Access Immunoassay Analyzers to aid in the following: 1. Diagnosis of patients suspected of having acute heart failure in the Emergency Department 2. Assessment of heart failure severity 3. Risk stratification of patients with heart failure 4. Risk stratification of patients with acute coronary syndrome

Source page: https://510kreport.com/device/K262109
Methodology: https://510kreport.com/methodology