# K051787: Triage BNP Test, Model 98000XR

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Sep 22, 2005 after 83 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: 3 generations back to DEN000010 (2000). 4 ancestors in all.
6 later devices descend from it; 3 cite it directly.
1 of 11 devices in its family (counting itself) has 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 1.
- K032646: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2003) Summary page 1.

## Most influential descendants
- K052789: Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 (2006), 4 descendants of its own
- K080269: Triage Cardioprofiler and Profiler S.O.B. Panels (2008), 3 descendants of its own
- 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

## Indications for use
The Triage® BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Triage Meter or Triage MeterPlus for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the: * Diagnosis of heart failure * Assessment of heart failure severity of * Risk stratification of patients with acute coronary syndromes * Risk stratification of patients with heart failure

Source page: https://510kreport.com/device/K051787
Methodology: https://510kreport.com/methodology