VisuCon-F Low Fibrinogen Control Plasma
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150144 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 VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from defibrinated human plasma. It is designed for use in the quality control of quantitative fibrinogen assays, specifically within the low abnormal range.
This device is supplied as a single-use, non-sterile reagent intended for laboratory use. It is classified as a Class II medical device under FDA regulations (864.5425) and has received FDA 510(k) clearance (K150144) as substantially equivalent to its predicate device. Storage and handling should follow standard laboratory protocols for plasma-based controls.
Frequently asked questions
What is the VisuCon-F Low Fibrinogen Control Plasma specifically used for in a laboratory setting?
This control plasma is designed exclusively for quality control purposes in quantitative fibrinogen assays, particularly to verify accuracy within the low abnormal range of fibrinogen levels. It helps laboratories ensure their testing methods are reliable when measuring lower-than-normal fibrinogen concentrations.
Is the VisuCon-F Low Fibrinogen Control Plasma intended for single-use or repeated use?
The device is explicitly labeled as a single-use reagent, meaning it should not be reused after opening. This ensures consistency in test results and maintains the integrity of the control plasma’s intended performance for quality control purposes.
How should the VisuCon-F Low Fibrinogen Control Plasma be stored, and why?
While the device is non-sterile, storage and handling should follow standard laboratory protocols for plasma-based controls. This ensures stability and reliability of the control plasma’s fibrinogen levels, which are critical for accurate quality control in assays.
What regulatory pathway was followed for FDA clearance of this device?
The VisuCon-F Low Fibrinogen Control Plasma received FDA 510(k) clearance (K150144) through the traditional review pathway, demonstrating substantial equivalence to its predicate device. The device is classified under FDA code 864.5425 as a Class II medical device, with the Hematology panel overseeing its review.
Why is the VisuCon-F Low Fibrinogen Control Plasma prepared from defibrinated human plasma?
The plasma is defibrinated to create a standardized, low-fibrinogen baseline for quality control testing. This allows laboratories to accurately assess the performance of their fibrinogen assays in the clinically relevant low-abnormal range, ensuring reliable diagnostic results.
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: VisuCon-F Low Fibrinogen Control Plasma (K150144) — FDA 510 (k ..., PDF Affinity Biologicals Inc. Denise Foulon Scientific Director 1348 ..., AccessGUDID - DEVICE: VisuCon-F Low Fibrinogen Control Plasma ..., Affinity Biologicals Inc LFGCP0181 VisuCon-F Low Fibrinogen Control Plasma
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150144 | Class II | Active |
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Manufacturer
- Manufacturer
- Affinity Biologicals Inc
- FDA Applicant
- Affinity Biologicals, Inc.
Sources (1)
- FDA 510(k) K150144 24 fields · synced Sep 19, 2026