T-Tek
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- T-tek EUDAMEDFDA UDI
- Generic Name
- Thrombin time (TT) IVD, kit, clotting FDA UDI
- Device Name
- T-Tek EUDAMEDThrombin Time 10 x 1 ml FDA UDI
- Model / Reference
- 50-201 EUDAMEDFDA UDI
- Description
- Thrombin Time 10 x 1 ml FDA UDI
Identifiers
- Catalog Number
- 50-201 FDA UDI
- Primary DI / UDI-DI
- 10859394006054 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10859394006054 EUDAMED
- 510(k) Number
- FDA Product Code
- GJA FDA 510(k)FDA UDI
- EMDN Code
- W0103020103 THROMBIN TIME / REPTILASE / BATROXOBIN TIME EUDAMED
- GMDN Term
- Thrombin time (TT) IVD, kit, clotting FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 864.7875 FDA 510(k)
- Regulation Number
- 864.7875 FDA 510(k)FDA UDI
- Market of Registration
- Italy 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
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The T-Tek Thrombin Time Reagent is a diagnostic in vitro device classified under the nomenclature for coagulation tests. It is designed for the quantitative measurement of thrombin time (TT) in citrated human plasma, a key parameter in assessing blood coagulation function and identifying potential clotting disorders.
This reagent is intended for use exclusively in clinical laboratories by qualified personnel, compatible with manual or semi-automated/automated coagulation analyzers. Supplied as a sterile, single-use reagent, it adheres to FDA 510(k) clearance (K050817) and IVDD compliance, with regulatory classification as a Class II device (GJA product code). Storage and handling follow standard laboratory protocols for coagulation reagents.
Frequently asked questions
What clinical purpose does the T-Tek Thrombin Time Reagent serve in a lab setting?
The T-Tek Thrombin Time Reagent is used to quantitatively measure thrombin time (TT) in citrated human plasma, which helps evaluate blood coagulation function and detect potential clotting disorders. This test is essential for identifying abnormalities in fibrin formation, such as those caused by fibrinogen deficiencies or the presence of fibrin degradation products.
Is the T-Tek Thrombin Time Reagent compatible with specific types of coagulation analyzers?
Yes, the T-Tek Thrombin Time Reagent is designed for use with both manual coagulation testing methods and semi-automated or fully automated coagulation analyzers commonly found in clinical laboratories. This versatility ensures flexibility depending on the lab’s workflow and equipment.
How is the T-Tek Thrombin Time Reagent supplied, and is it reusable?
The T-Tek Thrombin Time Reagent is supplied as a sterile, single-use reagent. This design ensures consistency and safety, as reuse could compromise accuracy or introduce contamination risks, which is critical for reliable coagulation testing.
What storage and handling guidelines should be followed for the T-Tek Thrombin Time Reagent?
The reagent follows standard laboratory protocols for coagulation reagents, which typically include storage at controlled temperatures (often 2–8°C) and protection from light and moisture. Always refer to the manufacturer’s instructions for precise storage conditions to maintain reagent integrity and test accuracy.
How does the regulatory classification of the T-Tek Thrombin Time Reagent impact its use in clinical settings?
The T-Tek Thrombin Time Reagent is classified as a Class II medical device under FDA regulations (product code GJA) and has received FDA 510(k) clearance (K050817), indicating it meets established safety and performance standards. This classification ensures it is subject to rigorous review but also allows for broader clinical use in accredited laboratories, provided it is used as intended for coagulation testing.
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: T-Tek - r² Diagnostics, PDF K05 1,I7 - Food and Drug Administration, T-Tek - r² Diagnostics
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K050817 | Class II | Active |
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Manufacturer
- Manufacturer
- R2 Diagnostics, Inc.
Sources (3)
- FDA 510(k) K050817 24 fields · synced Sep 18, 2026
- FDA UDI b4606a44-5e26-4524-aa88-5c9b8b6a173a 35 fields · synced May 30, 2026
- EUDAMED 52cdbafa-7459-4943-bf01-efc818645beb 61 fields · synced Jul 25, 2026