Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act. Pc-R Control Plasma and Biophen
510(k) K083729
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083729 | Date8 May 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GGW
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7925
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Factor V Leiden quantitative calibrator and control plasma designed for use in clotting assays. It provides lyophilized, undiluted human plasmas at defined Factor V-Leiden (FV-L) concentrations, enabling precise calibration of quantitative assays for measuring FV-L activity. The calibrator and control plasma are used in conjunction with the Hemoclot Quanti-V-L assay to distinguish between normal, heterozygous, and homozygous Factor V Leiden mutations by quantifying %FV-L concentration under physiological conditions, including the presence of Protein S.
The Hemoclot Quanti-V-L Factor V-L Calibrator and Biophen ACT PC-R Control Plasma are supplied as lyophilized human plasmas for in vitro diagnostic use. They are intended for single-use calibration and quality control in hematology laboratories performing quantitative APC resistance assays. The device is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance (K083729) as substantially equivalent to a predicate device. Storage and handling follow standard IVD protocols to maintain sterility and accuracy.
Questions
AI-generated answers, 1 Oct 2026
What is the Hemoclot Quanti-V-L Factor V-L Calibrator used for?
The Hemoclot Quanti-V-L Factor V-L Calibrator is designed for precise calibration of quantitative assays measuring Factor V Leiden (FV-L) activity. It provides lyophilized human plasma at defined FV-L concentrations, enabling laboratories to accurately quantify %FV-L levels under physiological conditions, including the presence of Protein S. This helps distinguish between normal, heterozygous, and homozygous Factor V Leiden mutations in clotting assays.
How is the Hemoclot Quanti-V-L Factor V-L Calibrator and control plasma supplied?
The device is supplied as lyophilized human plasmas, which means the plasmas are dried to extend shelf life while maintaining stability. They are intended for single-use calibration and quality control in hematology laboratories performing quantitative activated protein C resistance (APC resistance) assays. The lyophilized form ensures ease of storage and transport without compromising accuracy.
Is the Hemoclot Quanti-V-L Factor V-L Calibrator sterile?
The Hemoclot Quanti-V-L Factor V-L Calibrator and Biophen ACT PC-R Control Plasma are manufactured following standard in vitro diagnostic (IVD) protocols to maintain sterility and accuracy. As with all lyophilized IVD products, proper storage and handling are critical to preserve sterility and performance. Always follow manufacturer guidelines for reconstitution and use.
Can the Hemoclot Quanti-V-L Factor V-L Calibrator and control plasma be reused?
No, the Hemoclot Quanti-V-L Factor V-L Calibrator and Biophen ACT PC-R Control Plasma are intended for single-use only. Reuse of these materials could compromise the accuracy of assay results due to potential contamination or degradation of the lyophilized plasma. Each vial is designed for one calibration or quality control procedure to ensure reliable and reproducible measurements.
What storage conditions are required for the Hemoclot Quanti-V-L Factor V-L Calibrator?
The device must be stored according to standard IVD protocols to maintain its integrity. Typically, lyophilized plasmas like these are stored refrigerated (between 2°C and 8°C) to prevent degradation. Avoid freezing and protect from light and moisture. Always check the manufacturer’s instructions for specific storage details, as improper storage can affect the accuracy of the calibrator and control plasma.