# K052789: Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jan 23, 2006 after 112 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN000010 (2000). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033383: Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200, Biosite Incorporated (2003) Summary page 1.
- K021317: Triage B-Type Natriuretic Peptide (BNP) Test, Biosite Incorporated (2002) Summary page 1.
- K051787: Triage BNP Test, Model 98000XR, Biosite Incorporated (2005) Summary page 2.

## Most influential descendants
- K093758: BGM Galectin -3 (2010), 2 descendants of its own
- K252169: Access BNP II (2026), 0 descendants of its own
- K140436: ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (2014), 0 descendants of its own
- K111452: Presage ST2 Assay (2011), 0 descendants of its own

## Recalls of this device
- Mar 20, 2014 · Class II · Z-1540-2014: These lots may not recover within range when tested using certain commercially available controls.

## Indications for use
The Triage BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) 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 as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.

Source page: https://510kreport.com/device/K052789
Methodology: https://510kreport.com/methodology