# K063662: Ramp NT-Probnp Assay

- Pathway: 510(k) (Traditional)
- Applicant: Response Biomedical Corp.
- Decided: Jul 21, 2008 after 591 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: 4 generations back to DEN000010 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022516: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2002) Summary page 1.
- K032646: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2003) Summary page 1.
- K051382: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2005) Summary page 1.
- K051596: Statusfirst CHF (Congestive Heart Failure) NT-Probnp, Model 20204, Nanogen, Inc. (2006) Summary page 1.

## Indications for use
The RAMP NT-proBNP Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used to measure N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in EDTA whole blood. Measurement of NT-proBNP aids in the diagnosis and assessment of severity in individuals suspected of having heart failure and may aid in the risk stratification of patients with heart failure.

Source page: https://510kreport.com/device/K063662
Methodology: https://510kreport.com/methodology