Helena Thromboplastin Reagent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K892050 FDA 510(k)
- FDA Product Code
- GJS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7750 FDA 510(k)
- Regulation Number
- 864.7750 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Helena Thromboplastin Reagent is a calcified rabbit brain thromboplastin suspension used for measuring prothrombin time (PT) and assessing the extrinsic coagulation pathway in citrated human plasma. It serves as a diagnostic tool for monitoring oral anticoagulant therapy and evaluating coagulation disorders.
This ready-to-use liquid reagent is supplied in vials of 5 mL, with typical packaging configurations such as 8 x 5 mL or 10 x 5 mL, sufficient for approximately 250 tests. It is intended for use in microbiology laboratories and diagnostic centers, with a low International Sensitivity Index (ISI) of approximately 1.1, ensuring consistent performance for detecting liver disease, vitamin K-dependent factor deficiencies, and coumarin-induced coagulation abnormalities. The device holds an FDA 510(k) clearance under classification GJS and is regulated under 21 CFR 864.7750.
Frequently asked questions
What clinical conditions can the Helena Thromboplastin Reagent help diagnose or monitor?
The Helena Thromboplastin Reagent is designed to measure prothrombin time (PT) in citrated human plasma, which helps assess the extrinsic coagulation pathway. Clinically, it is used to monitor oral anticoagulant therapy (such as warfarin) and evaluate coagulation disorders like liver disease or vitamin K-dependent factor deficiencies, including those caused by coumarin-induced abnormalities.
How is the Helena Thromboplastin Reagent supplied, and how many tests can one vial perform?
The reagent comes as a ready-to-use liquid in 5 mL vials, typically packaged in configurations like 8 or 10 vials per box. Each 5 mL vial is sufficient for approximately 250 tests, making it suitable for routine use in microbiology laboratories and diagnostic centers.
Is the Helena Thromboplastin Reagent single-use or reusable, and what storage considerations apply?
The Helena Thromboplastin Reagent is intended for single-use per vial, as it is a liquid suspension designed for diagnostic testing. Storage details are not explicitly stated in the data, but typical thromboplastin reagents should be stored refrigerated (2–8°C) and protected from light to maintain stability and performance.
What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?
The Helena Thromboplastin Reagent received FDA clearance through a Traditional 510(k) pathway under product code GJS, classified as a Class II device (as indicated by OpenFDA data). It was reviewed by the Hematology (HE) Advisory Committee and holds a Substantially Equivalent (SESE) decision, regulated under 21 CFR 864.7750.
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: Thromboplastin L - Helena Biosciences, Thromboplastin L - Helena Biosciences (8 x 5 ml) - MEGALAB, Helena Thromboplastin-LI Reagent Kit 10 x 5 mL
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K892050 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K892050 24 fields · synced Sep 19, 2026