# K042347: Modification to Dimension NT-Probnp Flex Reagent Cartridge Method

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 19, 2004 after 81 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.
- K022516: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2002) Summary page 2.

## Most influential descendants
- K071767: Dimensions PBNP Flex Reagent Cartridge, Model RF423A (2007), 0 descendants of its own

## Indications for use
The Dimension® PBNP Flex® method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis of individuals suspected of having congestive heart failure and for risk stratification and severity assessment of patients with acute coronary syndrome and heart failure.

Source page: https://510kreport.com/device/K042347
Methodology: https://510kreport.com/methodology