# K061795: Dimension Vista PBNP Flex Reagent Cartridge and Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 11, 2006 after 80 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.
5 later devices descend from it; 1 cites 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)
- 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
- K080578: Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge (K6423A), Dimension Vista (2008), 4 descendants of its own
- 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 VistaTM 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 fhilure. The Dimension VistaTM NT-proBNP (PBNP) calibrator is an in vitro diagnostic product for the calibration of the N-terminal pro-brain natriuretic peptide (PBNP) method on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K061795
Methodology: https://510kreport.com/methodology