ACL Acustar D-Dimer, Hemosil Acustar D-Dimer Controls
by Instrumentation Laboratory CO EUDAMED510(k)
Active
510(k) K083518
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK083518 | Date13 Mar 2009 | 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- Withdrawn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
- Full name
- Acl Acustar, Hemosil Acustar D-Dimer, Hemosil Acustar D-Dimer Controls
- 510(k) Number
- FDA Product Code
- JPA
- 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 ACL Acustar D-Dimer is a System, Multipurpose for In Vitro Coagulation Studies, designed for the quantitative measurement of D-dimer in human plasma. It functions as an immunoassay system to detect fibrin degradation products, aiding in the diagnosis of venous thromboembolism, deep vein thrombosis, and pulmonary embolism. The device operates within a hematology workflow, providing objective results for clinical assessment of coagulation disorders.
This system is supplied as an in vitro diagnostic reagent kit, intended for single-use in laboratory settings. It is classified as a Class II medical device under FDA regulations and complies with the In Vitro Diagnostic Regulation (IVDR). The controls (Hemosil Acustar D-Dimer Controls) are included for quality assurance, ensuring accurate assay performance. Sterility and proper storage conditions are critical, as outlined in the accompanying instructions for use.
Other devices from Instrumentation Laboratory Company
Questions
AI-generated answers, 18 Sep 2026
What clinical conditions is the ACL Acustar D-Dimer assay primarily used to diagnose or monitor?
The ACL Acustar D-Dimer is designed for the quantitative measurement of D-dimer in human plasma, which helps detect fibrin degradation products. Clinically, it aids in diagnosing venous thromboembolism, deep vein thrombosis, and pulmonary embolism by providing objective results for assessing coagulation disorders within a hematology workflow.
Is the ACL Acustar D-Dimer system intended for single-use or repeated use in a laboratory setting?
The ACL Acustar D-Dimer is supplied as a single-use reagent kit for laboratory settings. This ensures sterility and consistency in assay performance, as reuse could compromise accuracy and regulatory compliance.
How are the controls (Hemosil Acustar D-Dimer Controls) incorporated into the system, and why are they important?
The Hemosil Acustar D-Dimer Controls are included as part of the kit for quality assurance, ensuring the accuracy and reliability of the assay results. They help validate the performance of the system by providing reference values for calibration and monitoring precision, which is critical for clinical decision-making.
What regulatory pathways has the ACL Acustar D-Dimer system undergone, and what does this mean for its use?
The ACL Acustar D-Dimer has been cleared through the FDA’s 510(k) pathway, specifically under the Traditional route, and complies with the In Vitro Diagnostic Regulation (IVDR). This means it has been evaluated for safety and effectiveness as a Class II medical device and meets regulatory standards for use in clinical hematology settings.
What storage conditions are necessary to maintain the integrity of the ACL Acustar D-Dimer reagents?
While the exact storage conditions are detailed in the accompanying instructions for use, the device data emphasizes that sterility and proper storage are critical for maintaining performance. Typically, such immunoassay reagents require refrigeration (e.g., 2–8°C) and protection from light until use, as outlined in the manufacturer’s guidelines.