# K033383: Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Dec 23, 2003 after 61 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
No predicates in its family tree.
5 later devices descend from it; 2 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)
- None. The FDA summary names its predicate without a number.
- (no number) Biosite Triage BNP test: named in the summary without a submission number

## Most influential descendants
- K052789: Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 (2006), 4 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
- K111452: Presage ST2 Assay (2011), 0 descendants of its own

## Recalls of this device
- Oct 1, 2020 · Class II · Z-0297-2021: Product compromised during shipment.

## Indications for use
The Triage® BNP test is intended for use with the 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 used as an aid in the diagnosis and assessment of severity of congestive heart failure. The test also is used for the risk stratification of patients with acute coronary syndromes.

Source page: https://510kreport.com/device/K033383
Methodology: https://510kreport.com/methodology