# K080578: Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge (K6423A), Dimension Vista

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 16, 2008 after 74 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). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061795: Dimension Vista PBNP Flex Reagent Cartridge and Calibrator, Dade Behring, Inc. (2006) Summary page 1.

## Most influential descendants
- K113373: Dimension Vista Loci 9 Calibrator- Loci 9 Cal (2011), 1 descendant of its own
- K130698: Dimension Vista Progesterone Calibrator (Prog Cal) (2013), 0 descendants of its own
- K082680: Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model RC623 (2008), 0 descendants of its own
- K082645: Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge, Model RF623 (2008), 0 descendants of its own

## Indications for use
The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista® System. In individuals suspected of having congestive heart failure (CHF), 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. The PBNP CAL is an in vitro diagnostic product for the calibration of the N-Terminal Pro-Brain Natriuretic Peptide (PBNP) method for the Dimension Vista® System.

Source page: https://510kreport.com/device/K080578
Methodology: https://510kreport.com/methodology