# K033606: Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Jan 30, 2004 after 74 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: 1 generation back to K021317 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021317: Triage B-Type Natriuretic Peptide (BNP) Test, Biosite Incorporated (2002) Summary page 2.

## Most influential descendants
- K060964: Architect BNP Assay, Model 8K28 (2006), 0 descendants of its own

## Indications for use
AxSYM ® BNP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

Source page: https://510kreport.com/device/K033606
Methodology: https://510kreport.com/methodology