IBDoc Mobile fCAL Reader

Overview

IBDoc® is an innovative in vitro diagnostic immunoassay designed for the quantitative determination of fecal calprotectin in human stool. It serves as a valuable tool for assessing inflammation of the intestinal mucosa, particularly in cases of inflammatory bowel disease (IBD), such as Crohn's Disease and Ulcerative Colitis.

App Features

The IBDoc® app is an essential component of the IBDoc® calprotectin home test. It enables users to measure the calprotectin concentration in a stool sample using their smartphone. The app includes a comprehensive tutorial that guides users through each step of the test procedure, from collecting the stool sample to preparing the pregnancy test-like test cassette.

Once the test cassette is ready, the IBDoc® app utilizes the mobile device's camera to capture an image of the test cassette. The optical signal from the test is then analyzed using a specific barcode on the cassette. The signal is translated into a clear result indicating the calprotectin concentration in the stool sample.

Data Management and Security

The test information is managed directly on the smartphone and simultaneously transmitted via a secure and encrypted connection to the IBDoc® Portal. Both the test results and associated patient information are securely stored on the portal, accessible only by the patient and their responsible healthcare practitioner.

Key App Features

• Tutorial: Detailed instructions with schematic drawings and text to guide users through each step of the test.
• Test History: A list of all test results performed by the patient.
• Help Menu: Access to a tutorial video and support contact for assistance.

Important Notices

• The IBDoc® app requires an IBDoc® Account, which must be set up by a healthcare practitioner. For more information, please contact your IBD doctor or clinic.
• Before conducting your first test, carefully review the Instruction for Use provided in the IBDoc® test kit.
• The app has been validated for specific smartphone models to ensure accurate results. Refer to the list of validated smartphones on www.ibdoc.net/support.
• A data connection is necessary for the app to function. Additional costs may apply based on your carrier.

Regulatory Compliance

BÜHLMANN Laboratories AG declares that the IBDoc® app and portal meet the provisions of the IVD Regulation (EU) 2017/746 for in vitro diagnostic medical devices, the Canadian Medical Devices Regulations SOR/98-282, and are in conformity with other relevant Union legislation, common specifications (CS), and normative documents.

• CE-marked Product: CE0123
• Health Canada License: 98903

In the United States, IBDoc® is available for investigational use only and should not be used for diagnostic procedures.

Trademarks

IBDoc® and CALEX® are registered trademarks of BÜHLMANN Laboratories AG in many countries.