Identifiers
- 510(k) Number
- K161316 FDA 510(k)
- FDA Product Code
- GGN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The George King Coumadin Plasma is a coagulation control plasma derived from single human donors stabilized on Coumadin therapy. It functions as a quality control material for monitoring the accuracy of coagulation assays, specifically for prothrombin time (PT) and international normalized ratio (INR) measurements in hematology testing. This product is classified as a plasma-based control for coagulation studies, ensuring reliable calibration in laboratory settings.
Supplied as a liquid, the George King Coumadin Plasma is intended for single-use in clinical laboratories. It is not sterile as a final product but is prepared from human plasma under regulated conditions. The device is classified under FDA regulation 864.5425 and holds a 510(k) clearance (K161316) for use in coagulation control applications. Storage and handling follow standard laboratory protocols for human plasma-based controls, with no specific MRI safety considerations.
Frequently asked questions
What is the George King Coumadin Plasma used for in a clinical lab?
The George King Coumadin Plasma is a coagulation control plasma derived from human donors stabilized on Coumadin therapy. It is specifically designed to monitor the accuracy of prothrombin time (PT) and international normalized ratio (INR) measurements in hematology testing. By providing a standardized reference, it helps ensure reliable calibration of coagulation assays, which is critical for diagnosing and managing conditions like blood clotting disorders.
How is the George King Coumadin Plasma supplied and intended for use?
The George King Coumadin Plasma is supplied as a liquid in single-use vials, intended exclusively for clinical laboratory applications. It is not sterile as a final product but is prepared from human plasma under regulated conditions to maintain consistency. Due to its single-use nature, each vial is meant for one calibration or quality control procedure, reducing the risk of contamination or cross-sample error.
Is the George King Coumadin Plasma sterile, and what does that mean for its handling?
The George King Coumadin Plasma is not sterile as a final product. This means it is not processed to eliminate all microorganisms, which is typical for plasma-based controls derived from human sources. As a result, standard laboratory aseptic techniques should be followed when handling it, including using sterile pipettes and working in a clean environment to prevent contamination during use. Always refer to the manufacturer’s instructions for specific handling protocols.
Can the George King Coumadin Plasma be reused, or is it designed for single-use only?
The George King Coumadin Plasma is explicitly designed for single-use only. Reusing the plasma could compromise its integrity, introduce contamination, or alter its coagulation properties, leading to inaccurate PT and INR measurements. Single-use controls like this one are engineered to maintain consistency and reliability for one calibration or testing session, ensuring the highest standards of laboratory performance.
What storage and handling guidelines should be followed for the George King Coumadin Plasma?
The George King Coumadin Plasma should be stored and handled according to standard laboratory protocols for human plasma-based controls. This typically includes refrigeration at temperatures between 2°C and 8°C (36°F and 46°F) to preserve its stability and prevent degradation. Avoid freezing, as this can alter the plasma’s properties. Always check the manufacturer’s labeling for specific storage instructions, and ensure the product is protected from light and contamination during storage and use.
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: George Login » Das smarte Online Banking | Erste Sparkasse, Coumadin® Plasma - George King Bio-Medical, Inc., Home - George King Bio-Medical, Inc., George, das modernste Banking kennenlernen | Erste Sparkasse, George King Coumadin Plasma (K161316) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161316 | Class II | Active |
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Manufacturer
- Manufacturer
- George King Bio-Medical, Inc.
Sources (1)
- FDA 510(k) K161316 24 fields · synced Oct 1, 2026