General manufacturer information
Name of the software:
Mobile Healthcare Solutions GmbH
The CASC App is a medical device software intended for human use and, in combination with a stand-alone in vitro diagnostic device (test strip), fulfills the following specific medical purpose:
Investigation of a physiological process or condition
For this purpose, the CASC App analyzes the color representation of the test areas of the test strip after it has been used for its intended purpose. The CASC app uses the test strip manufacturer’s reference color values to display the values measured by the test strip in the app (hereinafter referred to as test results).
The CASC App provides information on possible dietary and/or lifestyle adjustments that are related to the analyte.
It also provides information about the analyte itself.
This information is of a general nature and not a recommendation for action based on a measured value.
The results of the CASC app serve exclusively as support when reading the test strip: a discrepancy between the value read by the user and the value determined by the app indicates an error in the reading. The user can either repeat the test or consult a doctor. The decisive measurement result is that of the underlying test, not that of the app.
The results are not intended as a basis for diagnostic or therapeutic decisions and do not themselves constitute a diagnostic or therapeutic recommendation. Furthermore, they are not intended for the monitoring of physiological processes or parameters.