# K113373: Dimension Vista Loci 9 Calibrator- Loci 9 Cal

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 30, 2011 after 44 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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.

## Most influential descendants
- K130698: Dimension Vista Progesterone Calibrator (Prog Cal) (2013), 0 descendants of its own

## Indications for use
The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.

Source page: https://510kreport.com/device/K113373
Methodology: https://510kreport.com/methodology