# K071767: Dimensions PBNP Flex Reagent Cartridge, Model RF423A

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 4, 2007 after 36 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: 4 generations back to DEN000010 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041417: Dimension NT-Probnp Flex Reagent Cartridge Method, Dimension PBNP Calibrator, Models RF423, RC423, Dade Behring, Inc. (2004) Summary page 1.
- K042347: Modification to Dimension NT-Probnp Flex Reagent Cartridge Method, Dade Behring, Inc. (2004) Summary page 1.

## Indications for use
The PBNP assay used on the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum or plasma. In individuals suspected of having congestive heart failure (ClHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.

Source page: https://510kreport.com/device/K071767
Methodology: https://510kreport.com/methodology