# K040425: Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Jun 14, 2004 after 117 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: 2 generations back to K010266 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031038: Advia Centaur B-Type Natriuretic Peptide (BNP) Assay, Bayer Healthcare, LLC (2003) Summary page 1.

## Most influential descendants
- K043228: Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays (2005), 0 descendants of its own

## Indications for use
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ACS:180® Automated Chemiluminescence System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. This assay is not intended for use on any other system. For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of and assessment of the severity of heart failure. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. This assay is not intended for use on any other system.

Source page: https://510kreport.com/device/K040425
Methodology: https://510kreport.com/methodology