Regulatory information
All information on approval, intended purpose, instructions for use and manufacturer labelling of ACS Pathfinder in one place – for users, quality management and procurement.
0197Intended purpose
ACS Pathfinder estimates the probability of a myocardial infarction in patients with clinically suspected acute non-ST-elevation myocardial infarction. It can be used as an aid in the diagnosis of NSTEMI and to identify patients who may qualify for outpatient management. The probability estimate must be evaluated and confirmed by the responsible healthcare professional in the context of all available clinical data, considering the applicable guidelines.
- Indication
- Clinical suspicion of acute non-ST-elevation myocardial infarction
- Patient population
- Adults ≥ 18 and < 98 years
- Intended users
- Physicians, nurses, emergency medical services staff after product-specific training
- Use environment
- Wherever hs-cTn, ECG and vital signs are available: emergency department, practice, EMS
Contraindications
- Suspected ST-elevation myocardial infarction on the ECG
- Age < 18 or > 98 years
- Heart rate < 34/min or > 184/min
- Haemodynamic instability
Key warnings
- Not a sole basis for diagnosis or discharge – the definite diagnosis is always made by a physician ("human in the loop").
- The model does not detect conditions that mimic MI (e.g. myocarditis, pulmonary embolism) and does not distinguish type 1 from type 2 MI.
- Validity depends on correct inputs and settings (assay, unit, limit of reporting, local MI prevalence).
- A permanent internet connection is required; offline use is not supported.
Instructions for use (eIFU)
The instructions for use are provided in electronic form only. They are available here at any time and in the application under "Instructions for use". Please read them in full before first use.
| Language | IFU version | Published | Software version | |
|---|---|---|---|---|
| Deutsch | 3.0 | 29 Jan 2026 | 1.0.7 | Download PDF ↓ |
| English | 3.0 | 29 Jan 2026 | 1.0.7 | Download PDF ↓ |
Manufacturer and labelling
Am Klaassol 1
21224 Rosengarten, Germany
info@acs-pathfinder.com
0197Conformity with the general safety and performance requirements of Annex I, Regulation (EU) 2017/745.
UDI-DI: 04262482340005
Date of manufacture and further labelling are shown in the application under "Product label".
Report an incident
If a serious incident occurs in connection with ACS Pathfinder, it must be reported to the manufacturer. In the European Union, the incident must also be reported to the competent authority of the respective country; in all other countries, the country-specific requirements apply.