# K022516: Elecsys Probnp Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 19, 2002 after 112 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: 1 generation back to DEN000010 (2000). 1 ancestor in all.
46 later devices descend from it; 9 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)
- DEN000010: Triage B-Type Natriuretic Peptide (BNP) Test, Biosite Incorporated (2000). Our reading of the summary gave K003475, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN000010, Triage B-Type Natriuretic Peptide (BNP) Test (Biosite Incorporated), granted Nov 20, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- 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
- K162895: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 (2017), 8 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. The Elecsys proBNP Immunoassay is intended for use as an aid in the diagnosis of individuals suspected of having congestive heart failure. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

Source page: https://510kreport.com/device/K022516
Methodology: https://510kreport.com/methodology