Regulatory Information

Device Description

Klarity modules consist of a diagnostic testing solution. An AI Health Risk Assessment algorithm which uses the health data of the individual to provide a health score and predict risk to chronic health diseases.

A range of at home blood diagnostic tests to further validate the HRA score and risk prediction to certain chronic health conditions.

A telemedicine utility which allows health data to be shared with healthcare professionals, and a B2B2C Employer Covid-19 risk, and health data management solution used to help manage potential covid-19 employment Risks.

Intended Use

Klarity uses health data of the individual to provide a health score and predict risk to chronic health diseases to deliver more precise and relevant recommendations to customers looking for advice on how to improve their health and wellbeing.

The device enables customers to better understand the relevance of their results in relation to their health goals, and to understand possible lifestyle changes for improving their overall health.

The device is not intended as a substitute for customers seeking emergency medical services, actual medical diagnosis or consultation with a doctor.

The information provided by the device does not constitute medical advice and/or recommendations for medical treatment, but focuses on general healthcare and lifestyle advice.

User Population

The device should only be used by adults (over 18 years old) and residents in the UK and EU.