# K032235: Modification to Triage B-Type Natriuretic Peptide (BNP) Test

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jan 28, 2004 after 191 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
No predicates in its family tree.
3 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Triage® B-Type Natriuretic Peptide (BNP) Test: named in the summary without a submission number

## Most influential descendants
- K093758: BGM Galectin -3 (2010), 2 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

## Indications for use
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is 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.

Source page: https://510kreport.com/device/K032235
Methodology: https://510kreport.com/methodology