Thrombin Clotting Time Reagent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K920147 FDA 510(k)
- FDA Product Code
- GJA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7875 FDA 510(k)
- Regulation Number
- 864.7875 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thrombin Clotting Time Reagent is a diagnostic in vitro device used to measure the time required for plasma fibrinogen to convert into fibrin under standardized conditions. It quantifies the activity of thrombin (activated factor II) and detects abnormalities in fibrinogen levels or the presence of interfering substances such as fibrin degradation products (FDPs) or heparin. This test is classified under coagulation assays and is primarily utilized in hematology for assessing clotting disorders.
The reagent is supplied as a liquid for manual or semi-automated coagulation testing systems, requiring mixing with plasma at 37°C. It is intended for single-use and must be stored under refrigeration to maintain stability. The device is authorized under FDA 510(k) clearance (K920147) and falls under Class II regulatory classification (product code GJA). No MRI safety or sterility specifications are noted in the available data.
Frequently asked questions
What is the Thrombin Clotting Time Reagent used for?
The Thrombin Clotting Time Reagent is an in vitro diagnostic device designed to measure the time it takes for plasma fibrinogen to convert into fibrin under controlled conditions. This test helps quantify thrombin (activated factor II) activity and identifies abnormalities in fibrinogen levels or interfering substances like fibrin degradation products (FDPs) or heparin. It is primarily used in hematology to assess clotting disorders.
How is the Thrombin Clotting Time Reagent supplied and used?
The reagent is supplied as a liquid intended for use with manual or semi-automated coagulation testing systems. It must be mixed with plasma at a temperature of 37°C to perform the test. The device is designed for single-use only, ensuring accuracy and reliability for each test.
What storage conditions are required for the Thrombin Clotting Time Reagent?
The reagent must be stored under refrigeration to maintain its stability and ensure accurate test results. Proper refrigeration prevents degradation and preserves the reagent’s performance for its intended use in coagulation testing.
Is the Thrombin Clotting Time Reagent sterile?
The available data does not specify sterility requirements for the Thrombin Clotting Time Reagent. However, since it is intended for single-use in a clinical setting, adherence to standard aseptic practices is recommended to prevent contamination.
What regulatory status does the Thrombin Clotting Time Reagent hold?
The Thrombin Clotting Time Reagent holds FDA 510(k) clearance under the classification of substantially equivalent (SESE) to a predicate device. It is classified as a Class II medical device under product code GJA and is intended for use in hematology.
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: PDF Thrombin Clotting Time Reagent - helena.com, Thrombin Time - Helena Biosciences, Coagulation | Helena Laboratories - Innovations for Science & Clinical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920147 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K920147 24 fields · synced Oct 1, 2026