EX-TEM, FIB-TEM, and AP-TEM for ROTEM Delta Thromboelastometry System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ROTEM® delta EUDAMEDROTEM® FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- ROTEM® delta EUDAMEDThe ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. FDA UDI
- Model / Reference
- 200100 EUDAMEDdelta System FDA UDI
- Description
- The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. FDA UDI
Identifiers
- Catalog Number
- 200100-US FDA UDI
- Primary DI / UDI-DI
- 04260160470020 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260160470020QR EUDAMED
- FDA Product Code
- JPA FDA 510(k)FDA UDIGGN FDA UDI
- EMDN Code
- W0202029001 THROMBELASTOGRAPHS EUDAMED
- GMDN Term
- Coagulation analyser IVD, laboratory, semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)FDA UDI
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
Yes
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The EX-TEM, FIB-TEM, and AP-TEM are diagnostic assays designed for in vitro coagulation studies using the ROTEM Delta Thromboelastometry System. These tests analyze clot formation, stability, and lysis in citrated whole blood samples, providing quantitative and qualitative insights into hemostatic function. The EX-TEM assesses intrinsic coagulation pathways, while the AP-TEM evaluates clot firmness under antifibrinolytic conditions, and the FIB-TEM specifically examines fibrinolysis dynamics.
These assays are supplied as single-use reagents for use with the ROTEM Delta System, a Class II medical device regulated under FDA 510(k) clearance (K101533) and IVDR compliance. They are intended for use in hematology laboratories and critical care settings, requiring no special storage conditions beyond refrigeration (2–8°C) and protection from light. The system and assays are MRI-unsafe due to electronic components and must be handled as in vitro diagnostics, adhering to manufacturer instructions for preparation and disposal.
Frequently asked questions
What specific coagulation pathways do the EX-TEM, FIB-TEM, and AP-TEM assays evaluate, and how do they differ from one another?
The EX-TEM assay evaluates the intrinsic coagulation pathway, providing insights into the overall clot formation process in citrated whole blood. The FIB-TEM focuses specifically on fibrinolysis dynamics, analyzing how the clot breaks down over time. Meanwhile, the AP-TEM assesses clot firmness under antifibrinolytic conditions, offering a measure of how stable the clot remains when fibrinolysis is inhibited. Each assay complements the others by targeting distinct aspects of hemostatic function.
Are these assays single-use, and if so, what are the implications for workflow and cost management in a clinical setting?
Yes, the EX-TEM, FIB-TEM, and AP-TEM assays are supplied as single-use reagents. This design ensures patient safety by eliminating cross-contamination risks and reduces the need for sterilization or reprocessing, simplifying workflow in hematology labs and critical care units. However, it may require clinicians to budget for higher reagent costs per test compared to reusable alternatives, though it streamlines inventory management and minimizes procedural complexity.
What storage requirements apply to these assays, and how should they be handled to maintain integrity before use?
The assays must be stored refrigerated between 2–8°C and protected from light to preserve their stability. No additional specialized storage conditions are required, making them practical for standard laboratory environments. Always follow the manufacturer’s instructions for handling and disposal to ensure accurate test results and compliance with in vitro diagnostic protocols.
Can these assays be used with any thromboelastometry system, or are they specifically designed for the ROTEM Delta system?
These assays are exclusively designed for use with the ROTEM Delta Thromboelastometry System. They are not compatible with other systems, as their formulation and performance parameters are optimized for the Delta’s analytical capabilities. Always verify system compatibility before use to ensure accurate and reliable coagulation analysis.
Are there any safety concerns related to MRI compatibility or disposal for these assays, and how should they be handled?
The ROTEM Delta system and its associated assays (including EX-TEM, FIB-TEM, and AP-TEM) are MRI-unsafe due to their electronic components. They must never be placed in an MRI environment. For disposal, follow standard in vitro diagnostic waste protocols, as they are intended for single-use and contain no hazardous materials beyond typical laboratory reagents. Adherence to manufacturer guidelines ensures safe and compliant handling.
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: FDA Browser - Cleared 510 (K) - EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM ..., EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA… - FDA.report, PDF REVIEW MEMORANDUM - Food and Drug Administration
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 | K101533 | Class II | Active |
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Manufacturer
- Manufacturer
- TEM Innovations GmbH
Sources (3)
- FDA 510(k) K101533 24 fields · synced Sep 18, 2026
- FDA UDI c544fe24-a06a-4c0f-9ba5-50436f76aa35 35 fields · synced May 30, 2026
- EUDAMED 6927eafc-3e9e-4404-acdf-c1c90c5aeccf 61 fields · synced Jul 23, 2026