# K103360: Dimension Vista Digitoxin Calibrator - DGTX Cal

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Corp.
- Decided: Dec 17, 2010 after 31 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: 4 generations back to K891093 (1989). 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)
- K033809: Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D, Dade Behring, Inc. (2004) Summary page 1.

## Indications for use
The DGTX CAL is an in vitro diagnostic product for the calibration of digitoxin on the Dimension Vista® System.

Source page: https://510kreport.com/device/K103360
Methodology: https://510kreport.com/methodology