Helena Thromboplastin Reagent with Diluent
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K905807 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 with Diluent is a calcified rabbit brain thromboplastin suspension used for measuring prothrombin time (PT) in citrated human plasma. It facilitates the assessment of the extrinsic coagulation pathway and monitors oral anticoagulant therapy by quantifying clotting time. This reagent is designed for laboratory testing in hematology, providing standardized results for clinical coagulation studies.
Supplied as a ready-to-use liquid, the reagent is intended for single-use in vitro diagnostic applications. It is classified as a Class II medical device under FDA regulations (21 CFR 864.7750) and holds a Traditional 510(k) clearance (K905807) with a Substantially Equivalent determination. The product is distributed in kits containing specified volumes (e.g., 5 mL or 10 mL vials) and requires storage under controlled conditions to maintain stability. No MRI safety or sterility claims are stated in the specifications.
Frequently asked questions
What is the Helena Thromboplastin Reagent with Diluent used for?
This reagent is specifically designed for measuring prothrombin time (PT) in citrated human plasma, enabling assessment of the extrinsic coagulation pathway. It is widely used in hematology laboratories to monitor oral anticoagulant therapy by quantifying clotting time, ensuring accurate and standardized clinical coagulation studies.
How is the Helena Thromboplastin Reagent supplied, and is it single-use?
The reagent is supplied as a ready-to-use liquid in kits containing vials of specified volumes, such as 5 mL or 10 mL. It is intended exclusively for single-use in vitro diagnostic applications, adhering to standard laboratory protocols for coagulation testing.
What storage conditions are required to maintain the stability of this reagent?
To preserve stability, the Helena Thromboplastin Reagent must be stored under controlled conditions as specified by the manufacturer. While exact storage details are not provided in the data, typical thromboplastin reagents require protection from extreme temperatures, light exposure, and contamination. Always refer to the product labeling for precise storage instructions.
Is this reagent sterile, and what are its regulatory classifications?
The provided data does not explicitly state that the Helena Thromboplastin Reagent is sterile. It is classified as a Class II medical device under FDA regulations (21 CFR 864.7750) and holds a Traditional 510(k) clearance (K905807) with a Substantially Equivalent determination, indicating it meets FDA standards for safety and effectiveness.
What sizes or models of this reagent are available?
The Helena Thromboplastin Reagent is available in kits containing vials of specified volumes, including 5 mL and 10 mL options. These volumes are tailored to accommodate different laboratory workflows and testing requirements, ensuring flexibility for routine coagulation assessments.
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, Product List | Helena Laboratories - Innovations for Science & Clinical ..., PDF REAGENTS - helena.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K905807 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K905807 24 fields · synced Oct 1, 2026