Overview; Intended Use - Siemens DCA Vantage Operator's Manual

1

Overview

Intended Use

The DCA Vantage system is a semi-automated, benchtop system. It is
designed to quantitatively measure the percent of Hemoglobin A1c in blood
and low concentrations of albumin in urine (microalbuminuria), creatinine in
urine, and the albumin/creatinine ratio in urine.
The DCA Vantage system is intended for professional use in a physician's
office or hospital laboratory. Tests performed using the DCA Vantage system
are intended for in vitro diagnostic use. As with all diagnostic tests, do not
base a definitive diagnosis on the results of a single test. A physician should
make a diagnosis after all clinical and laboratory findings are evaluated.
The system is a spectrophotometer that analyzes the intensity of the light
transmitted through the cartridge optical window and reports the results in
clinically meaningful units. No calculations are required by the user. When you
swipe a calibration card, the barcode reader reads the card and the system
automatically performs the calibration.
DCA Vantage Operator's Guide 13