# K110169: Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 7, 2011 after 77 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: 2 generations back to K992502 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060677: N Latex CDT, Dade Behring, Inc. (2006) Summary page 2.

## Indications for use
CDT CAL is an in vitro diagnostic product for the calibration of the carbohydrate-deficient transferrin (CDT) method on the Dimension Vista® System. CDT CON L is an assayed, low level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT). CDT CON H is an assayed, high level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).

Source page: https://510kreport.com/device/K110169
Methodology: https://510kreport.com/methodology