# K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Feb 5, 2008 after 166 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: 5 generations back to K931172 (1993). 10 ancestors in all.
20 later devices descend from it; 6 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051382: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2005) Summary page 3.
- K032089: Roche Diagnostics Elecsys Precicontrol Cardiac, Roche Diagnostics Corp. (2003) Summary page 3.
- K022516: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2002) Summary page 3.

## Most influential descendants
- 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
- K092649: Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160, 04842472-190 (2010), 5 descendants of its own
- K191595: ARCHITECT STAT High Sensitivity Troponin-I (2019), 2 descendants of its own
- K232164: Access NT-proBNP (2024), 1 descendant 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. Elecsys proBNP II 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 Elecsys and cobas e immunoassay analyzers. The Elecsys PreciControl Cardiac II is used for quality control of specified immunoassays on the Elecsys and cobas e immunoassay analyzers. The Elecsys proBNP II CalSet is used for calibrating the quantitative Elecsys proBNP II assay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K072437
Methodology: https://510kreport.com/methodology