# DEN000010: Triage B-Type Natriuretic Peptide (BNP) Test

- Pathway: De Novo (Post-NSE)
- Applicant: Biosite Incorporated
- Decided: Nov 20, 2000 after 5 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.
47 later devices descend from it; 2 cite it directly.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K022516: Elecsys Probnp Immunoassay (2002), 46 descendants of its own
- K032646: Elecsys Probnp Immunoassay (2003), 44 descendants of its own
- K051382: Elecsys Probnp Immunoassay (2005), 23 descendants of its own
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset (2008), 20 descendants of its own
- K082699: Elecsys Troponin I and Troponin I Stat Test Systems (2009), 9 descendants of its own

Source page: https://510kreport.com/device/DEN000010
Methodology: https://510kreport.com/methodology