ClearScreen App – Regulatory Information Hub

1. About the ClearScreen app

The ClearScreen app is not itself a medical device. The ClearScreen app is not CE or UKCA marked. It is a launcher that gives healthcare professionals secure access to separate software medical devices, each of which reads a specific rapid test.

The app, published as ClearScreen Test Reader (Powered by TestCard), is for professional use by organisations that have a ClearScreen account. It provides the welcome and sign-in screens, user and patient ID entry, test selection, and any screens shown after a result is recorded. An organisation’s administrators manage users, locations and results through a separate web portal.

These launcher functions have no medical purpose. They do not meet the definition of an in vitro diagnostic medical device under Regulation (EU) 2017/746 (IVDR) or the UK Medical Devices Regulations 2002. The medical functions are provided only by the medical device modules listed in section 3.

2. How the medical device modules work

Each medical device module in the ClearScreen app is a separate software-only in vitro diagnostic medical device. Each medical device module is CE and UKCA marked in its own right, for professional use, with its own intended purpose, and TestCard Limited is the legal manufacturer of each medical device module.

Separate from the launcher. Each module provides its own test instructions, timings and result reading. The launcher does not pass data to a module, or between modules, or change how each module works.

Enabled per organisation. A user sees only the modules their organisation has enabled. Most organisations use one or a few of the modules listed in section 3.

Instructions are in the individual medical device modules. Each module has no packaging and no printed ‘traditional’ instructions for use. Its instructions for use are the step-by-step screens within the test flow detailed in each medical device module and the respective App Info screen, which shows TestCard Limited as the manufacturer, intended use, performance characteristics and symbols.

Labelling for each module. The public labelling for each module is linked in section 3.

3. Available medical device modules

The ClearScreen app hosts software medical device modules, each reading one manufacturer’s rapid test. All are for in vitro diagnostic use by healthcare professionals.

Device (trade name)

Test it reads (test manufacturer)

Detects

Regulatory status

UDI-DI

Labelling

CoreDx Combo Antigen Test Reader

CoreDx Influenza A/B + Covid-19/RSV Combo Ag Test Cassette (Core Tests)

SARS-CoV-2, influenza A and B, RSV antigens