Hemosil D-Dimer HS 500 Controls
by Instrumentation Laboratory CO EUDAMED510(k)
Active
510(k) K090264
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK090264 | Date5 Feb 2010 | 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- Withdrawn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 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DAP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7320
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Hemosil D-Dimer HS 500 Controls are quality control materials designed for use with the D-Dimer HS 500 assay. This latex-enhanced immunoturbidometric assay quantifies D-Dimer antigen levels in citrated human plasma, supporting diagnostic evaluation in hematology. As a fibrinogen and fibrin split product antigen control, it aids in ensuring assay accuracy and reliability within laboratory workflows.
Supplied as part of the ACL TOP® Family Systems workflow, these controls are intended for automated use in clinical laboratories. They are not sterile or single-use but are regulated under the FDA 510(k) clearance (K090264) and the In Vitro Diagnostic Regulation (IVDR). Storage and handling follow standard laboratory protocols for diagnostic controls, with no specific MRI safety considerations. The product is classified as a Class II device under the FDA’s regulatory framework.
Other devices from Instrumentation Laboratory Company
Questions
AI-generated answers, 18 Sep 2026
Are these controls intended for use with any specific automated laboratory system, and if so, which one?
Yes, these controls are specifically designed for use within the ACL TOP® Family Systems workflow. They are optimized to ensure accurate performance and reliability when integrated into this automated laboratory platform, which is commonly used for hematology assays.
How should these controls be stored, and are there any special handling requirements?
Storage and handling follow standard laboratory protocols for diagnostic controls. Since they are not sterile, they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. No specific MRI safety considerations apply, as these are in vitro diagnostic materials meant for laboratory use only.
Are these controls reusable, or are they meant for single-use only?
These controls are not single-use; they are intended for repeated use within a laboratory setting, provided they are handled and stored according to standard diagnostic control protocols. Reusability is typical for quality control materials like these, as long as they remain within their specified stability period.
What regulatory pathways have been followed for this product, and what does that mean for clinical laboratories?
The Hemosil D-Dimer HS 500 Controls have undergone FDA 510(k) clearance (K090264) and comply with the In Vitro Diagnostic Regulation (IVDR). This means the product has been evaluated for substantial equivalence to a predicate device and meets EU regulatory standards for in vitro diagnostics, ensuring its suitability for clinical laboratory use in both the U.S. and EU markets.
What is the primary purpose of these controls in a clinical hematology workflow?
These controls serve as quality assurance materials to monitor and validate the accuracy and reliability of the D-Dimer HS 500 assay, which quantifies D-Dimer antigen levels in citrated human plasma. By using these controls, laboratories can ensure consistent performance of the assay, which is critical for diagnosing conditions related to fibrinogen and fibrin split products in hematology.