# K082645: Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge, Model RF623

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Sep 22, 2008 after 11 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 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)
- K080578: Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge (K6423A), Dimension Vista, Siemens Healthcare Diagnostics, Inc. (2008) Summary page 1.

## Recalls of this device
- Apr 12, 2010 · Not classified · Z-0461-2011: Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate t

## Indications for use
The NTP 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® EXLTM integrated chemistry system with LOCI® Module. 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.

Source page: https://510kreport.com/device/K082645
Methodology: https://510kreport.com/methodology