# K130698: Dimension Vista Progesterone Calibrator (Prog Cal)

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 5, 2013 after 22 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: 6 generations back to DEN000010 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113373: Dimension Vista Loci 9 Calibrator- Loci 9 Cal, Siemens Healthcare Diagnostics, Inc. (2011) Summary page 1.

## Indications for use
The PRO G CAL is an in vitro diagnostic product for the calibration of the Progesterone (PROS) assay on the Dimension Vista® System.

Source page: https://510kreport.com/device/K130698
Methodology: https://510kreport.com/methodology