# K252169: Access BNP II

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 24, 2026 after 257 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: 5 generations back to DEN000010 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052789: Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200, Biosite Incorporated (2006) Summary page 5.

## Indications for use
The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ∙ as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure ∙ for the risk stratification of patients with acute coronary syndromes ∙ for the risk stratification of patients with heart failure

Source page: https://510kreport.com/device/K252169
Methodology: https://510kreport.com/methodology