Hemosil D-Dimer HS 500 Control
by Instrumentation Laboratory EUDAMED510(k)
Active
510(k) K133582
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK133582 | Date15 Aug 2014 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GGN
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5425
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Hemosil D-Dimer HS 500 Control is a plasma-based coagulation control designed for use in laboratory testing. It serves as a reference material for calibrating and validating assays that measure D-dimer levels, a biomarker used to detect fibrin degradation products indicative of thromboembolic events.
This control is supplied as a liquid for in vitro diagnostic use and is intended for single-use applications in clinical hematology laboratories. It is regulated under the FDA’s 510(k) pathway and the EU’s In Vitro Diagnostic Regulation (IVDR), with a classification as a Class II device. Storage and handling follow standard laboratory protocols for liquid controls, ensuring stability and accuracy for diagnostic testing.
Other devices from Instrumentation Laboratory Company
Questions
AI-generated answers, 18 Sep 2026
What is the HEMOSIL D-Dimer HS 500 Control used for in a clinical lab setting?
The HEMOSIL D-Dimer HS 500 Control is a plasma-based reference material designed specifically for calibrating and validating assays that measure D-dimer levels. D-dimer is a biomarker used to identify fibrin degradation products, which are indicators of thromboembolic events like deep vein thrombosis or pulmonary embolism. This control ensures the accuracy and reliability of diagnostic testing for these conditions in clinical hematology laboratories.
How is the HEMOSIL D-Dimer HS 500 Control supplied, and is it intended for single-use?
The HEMOSil D-Dimer HS 500 Control is supplied as a liquid for in vitro diagnostic use. According to the manufacturer’s instructions, it is intended strictly for single-use applications in clinical hematology laboratories. This ensures consistency and prevents cross-contamination between tests.
What storage and handling requirements should be followed for this control?
Since the HEMOSIL D-Dimer HS 500 Control is a liquid plasma-based product, it should be stored and handled following standard laboratory protocols for liquid controls. This typically includes refrigeration (between 2°C and 8°C) and protection from light to maintain stability and accuracy for diagnostic testing. Always refer to the manufacturer’s instructions for precise storage guidelines.
Is this device regulated under specific pathways in the U.S. and EU, and what does that mean for its use?
Yes, the HEMOSIL D-Dimer HS 500 Control is regulated under the FDA’s 510(k) pathway in the U.S. and the EU’s In Vitro Diagnostic Regulation (IVDR). The 510(k) clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards. In the EU, compliance with IVDR ensures it adheres to rigorous requirements for diagnostic accuracy and traceability, reinforcing its reliability for clinical use.