Instructions for Use
1. Product Description
Klarity is a digital health platform providing personalised wellness risk assessment across three health domains: cancer awareness, cardiovascular wellbeing and metabolic health (including Type 2 diabetes).
The platform uses a proprietary Health Risk Assessment (HRA) methodology to analyse individual health data including lifestyle, demographic and general health history inputs, and generate a personal health awareness profile expressed as relative indicators against broader population reference ranges. Where available, the platform integrates wearable and optional health-related data to further contextualise health awareness outputs.
2. Intended Use
The application is intended to be used by laypersons aged 18 years and over via a web or mobile application.
The application includes a Health Information Feature that processes user-entered information to present general health and wellbeing information and awareness outputs. These outputs are descriptive and informational in nature and are based on user-provided inputs and general reference information only.
The application does not provide clinical interpretation and does not provide diagnostic or therapeutic advice. The outputs are not intended to be used for clinical decision-making or clinical triage.
The application is intended solely to support general health awareness and user engagement. Any decision to seek medical advice or further assessment is made independently by the user and is not directed by the application.
3. Contraindications
Klarity must not be used by individuals under the age of 18.
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.
4. 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.
5. Regulatory Status
United Kingdom: Class I Software as a Medical Device. Registered with the MHRA under UK MDR 2002 (as amended). UKCA marked.
European Union: Class I Software as a Medical Device under EU MDR 2017/745. CE marked. EUDAMED registered.
United States: Exempt from FDA medical device requirements under Section 520(o)(1)(B) of the FD&C Act (21st Century Cures Act wellness software exclusion). HIPAA compliance maintained.
UDI-DI: 5065009629008
6. EU Authorised Representative
Patient Guard Europe UG
Hauffstrasse 41
73765 Neuhausen
Germany
7. Manufacturer Contact
Managed Self Ltd t/a KLARITY
Alum House, 5 Alum Chine Road, Westbourne, Bournemouth, BH4 8DT, United Kingdom
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