Coagulation System for the Measurement of Whole Blood Viscoelastic Properties

A coagulation system designed to measure whole blood viscoelastic properties is an in vitro diagnostic (IVD) device used to evaluate blood coagulation, fibrinolysis, or both in patients.

A coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in perioperative patients, as an aid in the assessment of coagulopathies when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.

Intended Use: The system is intended to be used by trained professionals at the point of care and in clinical laboratories to evaluate the viscoelastic properties of whole blood using functional parameters like: Clot Time (CT), Clot Time with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Time Ratio (CTR).

Device Description: A coagulation system designed for measuring the viscoelastic properties of whole blood is an in vitro diagnostic device used to assess blood coagulation, fibrinolysis, or both in patients.

This device is available as an automated or semi-automated instrument, utilizing ultrasound-based technology for precise analysis. It operates with dedicated reagent cartridges to facilitate testing.

The system employs ultrasound technology to evaluate the coagulation characteristics of blood, providing accurate and real-time insights into clot formation, strength, and dissolution.

• Precision (Reproducibility and Repeatability)
• Accuracy
• Shelf-Life Reagent Stability
• In-Use Reagent Stability
• Specimen Stability
• Measuring range
• Sensitivity and Specificity
• Interference substance testing
• Software verification and validation

The same is applicable for CE Marking under IVDR also.

Clinical Testing is mandatory for 510k submission and IVDR CE Marking