# K082680: Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model RC623

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Oct 10, 2008 after 25 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- 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.

## Indications for use
The LOCI NTP CAL is an in vitro diagnostic product for the calibration of the N-terminal pro-brain natriuretic peptide (NTP Cat. No. RF623) method on the Dimension® EXLTM integrated chemistry system with LOCI® Module.

Source page: https://510kreport.com/device/K082680
Methodology: https://510kreport.com/methodology