# K041417: Dimension NT-Probnp Flex Reagent Cartridge Method, Dimension PBNP Calibrator, Models RF423, RC423

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 20, 2004 after 54 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 1.

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

## Indications for use
The Dade Behring Dimension® PBNP Flex® reagent cartridge 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. The Dade Behring Dimension® PBNP Calibrator is intended to be used to calibrate the N-terminal pro-brain natriuretic peptide (PBNP) method for the Dade Behring Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K041417
Methodology: https://510kreport.com/methodology