# K092649: Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160, 04842472-190

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 4, 2010 after 160 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: 6 generations back to K931172 (1993). 11 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset, Roche Diagnostics (2008) Summary page 2.

## Most influential descendants
- K210546: Elecsys proBNP II, Elecsys proBNP II STAT (2022), 1 descendant of its own
- K253539: Alere NT-proBNP for Alinity i (2026), 0 descendants of its own
- K241176: Alere NT-proBNP for Alinity i Reagent Kit (2025), 0 descendants of its own
- K223637: Elecsys proBNP II, Elecsys proBNP II STAT (2023), 0 descendants of its own
- K153301: Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (2016), 0 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 II STAT assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer. Elecsys proBNP II STAT CalSet is used for calibrating the quantitative Elecsys proBNP II STAT assay on the cobas e 601 immunoassay analyzer.

Source page: https://510kreport.com/device/K092649
Methodology: https://510kreport.com/methodology