# K051596: Statusfirst CHF (Congestive Heart Failure) NT-Probnp, Model 20204

- Pathway: 510(k) (Traditional)
- Applicant: Nanogen, Inc.
- Decided: Mar 13, 2006 after 270 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032646: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2003) Summary page 1.

## Most influential descendants
- K063662: Ramp NT-Probnp Assay (2008), 0 descendants of its own

## Indications for use
StatusFirst TM CHF (Congestive Heart Failure) NT-proBNP is a rapid test for the in-vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma. The device is intended for use with the DXpress TM Reader to provide quantitative results as an aid in the diagnosis of CHF.

Source page: https://510kreport.com/device/K051596
Methodology: https://510kreport.com/methodology