Sysmex America Secures FDA Clearance for CN-6000 Automated Blood Coagulation Analyzer

Key Insights

• Sysmex America received FDA clearance for the CN-6000™ Automated Blood Coagulation Analyzer, enabling high-throughput hemostasis testing for bleeding and clotting disorders.
• The clearance includes five commonly performed hemostasis tests with specific reagent products, including PT/INR, APTT, fibrinogen, antithrombin, and D-dimer assays.
• The analyzer offers fully automated testing in a space-saving footprint with expandable capacity to match different laboratory needs and workloads.

Sysmex America has received FDA clearance for its CN-6000™ Automated Blood Coagulation Analyzer, marking a significant advancement in hemostasis testing capabilities for clinical laboratories. The clearance encompasses the analyzer along with reagent products for five commonly performed hemostasis tests critical for diagnosing bleeding and clotting disorders.

Comprehensive Testing Portfolio

The FDA clearance includes specific reagent combinations for essential coagulation tests:

• Prothrombin Time (PT) and PT INR with Dade® Innovin®
• Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
• Fibrinogen (Fbg) with Dade® Thrombin Reagent
• Antithrombin (AT) with INNOVANCE® Antithrombin
• D-dimer with INNOVANCE® D-Dimer

"Sysmex's hemostasis solutions bring together advanced technology, trusted reagents and award-winning service to provide laboratories with reliable results for diagnosing patients suffering from bleeding or clotting disorders," said Dan Zortman, CEO of Sysmex America.

Advanced Laboratory Automation

The CN-6000 analyzer addresses the growing demand for efficient hemostasis testing in clinical laboratories. Zortman emphasized that the "CN-Series, CN-6000 analyzer, provides high throughput and fully automated testing in a space-saving footprint, that is expandable to match the needs of different laboratories."

For laboratories managing high workloads, the system offers an optional sampler that provides expandable sample loading capacity, allowing facilities to scale their testing capabilities according to demand.

Future Development Pipeline

Sysmex America continues its regulatory efforts to expand its hemostasis testing portfolio. The company is actively pursuing market authorization for the Automated Blood Coagulation Analyzer CN-3000 and additional reagent applications, indicating a comprehensive approach to meeting diverse laboratory needs.

Company Background

Sysmex America operates as the Americas regional affiliate of Kobe, Japan-based Sysmex Corporation, a global leader in clinical laboratory diagnostics. The company's diagnostic solutions span hematology, hemostasis, urinalysis, flow cytometry, and informatic systems. Forbes magazine recognized Sysmex as one of the most innovative companies in the healthcare equipment and services category, while the Center for Companies That Care named Sysmex America to its "Honor Roll."