Intended Use Statement

Last updated: 2026-04-21 · Document owner: Product & Legal

1. Product Category

Kalorix is a general wellness application intended to support healthy adults in building and maintaining healthy-eating habits. Kalorix is not a medical device within the meaning of:

• EU Regulation (EU) 2017/745 on medical devices (MDR)
• Directive 93/42/EEC (legacy)
• U.S. Federal Food, Drug, and Cosmetic Act, as amended by the 21st Century Cures Act (Section 520(o) – software functions not regulated as a device)
• Medical Device Coordination Group guidance MDCG 2019/11 on qualification and classification of software

Kalorix does not:

• Diagnose any disease, deficiency, or medical condition.
• Treat, cure, mitigate, or prevent any disease or condition.
• Monitor physiological processes for medical purposes.
• Interpret laboratory results or imaging.
• Provide individualized clinical advice.

2. Intended Purpose

To help users:

• Track meals, calories, and macronutrients.
• Receive AI-generated general healthy-eating suggestions and meal plans.
• Log personal wellness data (weight, activity, optional blood test values) for their own self-tracking.
• Maintain motivation and general lifestyle awareness.

3. Target Population

Kalorix is intended for generally healthy adults (18+) who wish to pursue general wellness goals.

Kalorix is not intended for and must not be used by:

• Minors (under 18).
• Pregnant or breastfeeding individuals.
• Individuals with diagnosed eating disorders.
• Individuals with chronic or acute medical conditions requiring clinical dietary management (e.g., diabetes, kidney disease, liver disease, cardiovascular disease, cancer).
• Individuals under active medical supervision.
• Any user intending to rely on the App for clinical decision-making.

These exclusions are communicated during onboarding, in our Terms of Use, and in our Medical Disclaimer.

4. Blood Test Log Feature

Kalorix offers an optional Blood Test Log feature. Under this feature, the App:

• Extracts printed parameter names and numeric values from images or text via OCR, strictly as a transcription service.
• Stores them as a personal log for the user.
• Does not interpret, classify, rate, diagnose, or compare against medical reference ranges.
• May, only with explicit user consent, use these values as a silent personalization signal when generating general meal suggestions. The values are never shown or referenced in user-facing text.
• Consent can be revoked at any time from the blood test detail screen.

5. Out-of-Scope Claims

Marketing, UI copy, and AI outputs must never claim or imply diagnosis of any condition, treatment or prevention of disease, interpretation of blood results or symptoms, or replacement of professional medical advice.

6. Guardrails

Technical and organizational guardrails include:

• A deterministic output safety filter that removes clinical-interpretation and biomarker-reference language in all user-facing AI outputs.
• Pure-OCR prompt enforcement for blood-test extraction (no interpretation).
• Consent-gated use of blood-log data for diet generation.
• Onboarding hard-gate acknowledgement that Kalorix is not a medical device and confirmation that the target-population exclusions do not apply.

7. Review

This statement is reviewed at least annually and upon any substantive change to the product's AI models, features, or intended use.