5 Alum Chine Road
Westbourne, Bournemouth
BH4 8DT
United Kingdom
Product Description
Klarity is a digital health platform providing personalised health risk assessment across three health domains: cancer, cardiovascular health and metabolic health, including Type 2 diabetes.
The platform uses a proprietary Health Risk Assessment (HRA) methodology, incorporating statistical and machine-learning models trained on published population cohort data, to analyse the user's lifestyle, demographic and health history inputs. It generates a personal risk profile expressed as relative indicators against population reference ranges. Where available, the platform integrates wearable and optional health-related data to refine those indicators.
Klarity is a software-only product. It contains no hardware component and performs no measurement of the user's body. It does not analyse images or samples itself: where a screening test is arranged through Klarity, that test is performed and reported by a separate provider under its own regulatory approvals.
Intended Use
Klarity is intended to be used by laypersons aged 18 years and over, via a web or mobile application, without supervision by a healthcare professional.
Intended purpose. Klarity processes information provided by the user, together with connected wearable and test data where available, to produce individual risk indicators for specified conditions and to present personalised prevention information. Its purpose is prediction and prognosis of the likelihood of disease, and the support of personal preventive action by the user.
Intended users. Adults aged 18 and over who wish to understand and act on their own health risk. Klarity is not intended for use by healthcare professionals in the course of providing care.
Intended clinical benefit. To help users identify elevated personal risk earlier than they otherwise would, and to prompt them to seek appropriate screening or professional advice.
What Klarity does not do. Klarity does not diagnose. It does not interpret results clinically, prescribe or recommend treatment, or triage users to a care pathway. Its outputs are not intended to be used by a healthcare professional as the basis of a diagnostic or therapeutic decision, and are not a substitute for consultation with a qualified healthcare professional. Any decision to seek medical advice or further assessment is made independently by the user.
Contraindications
- Klarity must not be used by individuals under the age of 18. This matches the minimum age in our Terms and Conditions.
- Klarity must not be used as a diagnostic tool and must not be used as the sole basis for any clinical decision.
- Klarity must not be used in emergency situations. If you believe you have a medical emergency, contact your local emergency services immediately.
Warnings and Precautions
- Risk scores generated by Klarity represent statistical probabilities relative to a population distribution. A low risk score does not confirm the absence of disease. A high risk score does not confirm the presence of disease.
- Klarity does not replace regular health check-ups with a GP, specialist or other qualified healthcare professional.
- If you have any concerns about your health, consult a qualified healthcare professional.
- Klarity's predictive models are trained on population cohort data. Risk estimates may be less precise for individuals from populations not well represented in the training dataset.
- Klarity outputs must not be used to make decisions relating to insurance, employment, underwriting or financial products.
- Klarity outputs depend entirely on the accuracy and completeness of the information you provide. Inaccurate or missing information will produce inaccurate risk indicators.
- Klarity is not a monitoring device. It does not detect deterioration in your condition and will not alert you or anyone else to a medical event.
- Klarity requires an internet connection and a supported device. It is not available offline.
Residual Risks and Undesirable Effects
We have assessed the risks associated with Klarity and reduced them as far as reasonably practicable. The following residual risks remain and cannot be fully eliminated by design. They are accepted as outweighed by the benefit of the product, and are disclosed here so that you can take them into account.
Reporting a Serious Incident
If a serious incident occurs in relation to Klarity, please report it to us at info@getklarity.io, marked for the attention of the Regulatory Affairs lead, and to the competent authority of the country in which you are established.
In the United Kingdom, report to the MHRA through the Yellow Card scheme at yellowcard.mhra.gov.uk. In the European Union, report to the competent authority of your member state.
A serious incident means any malfunction or deterioration in the characteristics or performance of the product, or any inadequacy in this information, that directly or indirectly led, might have led, or might lead to death or a serious deterioration in someone's state of health.
Regulatory Status
Klarity is a medical device. It is classified as Class I under both UK and EU rules, on the basis that its outputs are intended for the user's own preventive action and are not intended to be used to take diagnostic or therapeutic decisions about a patient.
Accessing These Instructions
These Instructions for Use are provided electronically rather than on paper. They are available at all times within the Klarity application and on this page.
Paper copy. You can ask us for a printed copy free of charge at any time, by emailing info@getklarity.io or writing to the address in section 10. We will send it within 7 calendar days of receiving your request.
Earlier versions. Every version of these Instructions we have issued remains available. Contact us and we will provide any earlier version and its date of issue.
Revisions. The version number and date of issue at the top of this page change whenever these Instructions are revised. Where a revision is necessary for safety reasons, we will notify users directly in the application and by email.
System requirements. These Instructions can be read in any current web browser and require no additional software. They are provided in English.
EU Authorised Representative
73765 Neuhausen auf den Fildern
Germanyinfo@patientguard.com
Manufacturer Contact
Managed Self Limited t/a Klarity
Alum House, 5 Alum Chine Road, Westbourne, Bournemouth, BH4 8DT, United Kingdom
For support and enquiries, visit: www.klarity.health
