# K031038: Advia Centaur B-Type Natriuretic Peptide (BNP) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Jun 23, 2003 after 83 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010266 (2001). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010266: Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000, Biosite Incorporated (2001) Summary page 1.

## Most influential descendants
- K192380: ST Aia-Pack BNP (2020), 1 descendant of its own
- K040425: Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays (2004), 1 descendant of its own
- K211199: ST AIA-PACK BNP Assay (2021), 0 descendants of its own
- K043228: Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays (2005), 0 descendants of its own

## Recalls of this device
- Dec 18, 2017 · Class II · Z-2053-2018: In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3R
- Oct 6, 2014 · Class III · Z-0229-2015: Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur Systems BNP reagent contains an ADVIA Centaur Systems FT4 human-readable side label.
- Jun 23, 2014 · Class II · Z-2149-2014: Complaints of failed calibration.
- Jun 23, 2014 · Class II · Z-2150-2014: Complaints of failed calibration.
- Nov 14, 2012 · Class II · Z-0506-2013: Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur syst
- Jul 25, 2012 · Class II · Z-2313-2012: Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays

## Indications for use
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 heart failure. This assay is not intended for use on any other system.

Source page: https://510kreport.com/device/K031038
Methodology: https://510kreport.com/methodology