ROTEM sigma Thromboelastometry System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201440 FDA 510(k)
- FDA Product Code
- JPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ROTEM sigma Thromboelastometry System is a multipurpose in vitro coagulation analysis device designed for rotational thromboelastometry. It provides real-time, viscoelastic assessment of blood clotting dynamics, enabling precise evaluation of clot formation, strength, and lysis. This system supports clinical decision-making in hematology and transfusion medicine by offering detailed insights into coagulation disorders and bleeding risks.
The system is intended for use in clinical laboratories, operating rooms, and intensive care units, where it is employed to monitor coagulation status during major surgeries, trauma, and critical care scenarios. Supplied as a reusable medical device, it requires appropriate sterilization and maintenance protocols. The ROTEM sigma adheres to FDA 510(k) and IVDR regulatory standards, with multiple registration numbers under classification II (device class 2) for in vitro coagulation studies. Storage and handling follow manufacturer guidelines to ensure accuracy and reliability.
Frequently asked questions
What clinical settings is the ROTEM sigma Thromboelastometry System primarily used in, and why is it beneficial there?
The ROTEM sigma is designed for use in clinical laboratories, operating rooms, and intensive care units. It provides real-time, viscoelastic assessment of blood clotting dynamics, which helps clinicians evaluate clot formation, strength, and lysis. This is particularly valuable during major surgeries, trauma cases, and critical care scenarios where precise coagulation monitoring is essential for managing bleeding risks and guiding transfusion decisions.
Is the ROTEM sigma Thromboelastometry System single-use or reusable, and what does that mean for maintenance?
The ROTEM sigma is supplied as a reusable medical device, meaning it is intended for repeated use after proper sterilization and maintenance. This requires adherence to manufacturer guidelines for cleaning, disinfection, and calibration to ensure accuracy and reliability over time, as outlined in the system’s operational protocols.
What regulatory standards does the ROTEM sigma adhere to, and how does that affect its use?
The ROTEM sigma complies with FDA 510(k) clearance and IVDR (In Vitro Diagnostic Regulation) standards, classified as a Class II medical device for in vitro coagulation studies. These regulatory pathways ensure its safety, performance, and suitability for clinical use in hematology and transfusion medicine, though they do not dictate its clinical indications—only that it meets stringent manufacturing and testing requirements.
How does the ROTEM sigma differ from traditional coagulation tests in terms of the information it provides?
Unlike traditional coagulation tests (e.g., PT/INR or aPTT), which only measure clotting time or factor deficiencies, the ROTEM sigma offers viscoelastic assessment, providing dynamic insights into clot formation, strength (maximum amplitude), and lysis (clot breakdown). This holistic view helps clinicians assess bleeding risks, guide anticoagulant therapy, and monitor coagulation disorders in real time during critical interventions.
What should buyers consider regarding storage and handling to maintain the device’s accuracy?
The ROTEM sigma requires careful storage and handling as specified by the manufacturer to preserve its performance. Since it is reusable, proper sterilization protocols must be followed between uses, and environmental conditions (e.g., temperature, humidity) should align with the manufacturer’s recommendations. Deviations could affect calibration, measurement consistency, or device reliability, particularly in settings like operating rooms or ICUs where precision is critical.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ROTEM® sigma | Werfen in Deutschland, ROTEM and TEG in ICU – Hemostasis Monitoring and Treatment, Basic Principles of Rotational Thromboelastometry (ROTEM, Thromboelastometry - Wikipedia, ROTEM delta | Werfen in Deutschland
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201440 | Class II | Active |
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Manufacturer
- Manufacturer
- TEM Innovations GmbH
Sources (2)
- FDA 510(k) K201440 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026