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The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density. DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate. The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR). For use with ONext. For clinical professional laboratory and prescription use only. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

QNext is designed to automatically perform all stages of the procedures associated to hemostasis tests allowing the operator to: - Absorb the workload involved in running hemostasis laboratory tests profiles, optimizing the execution of these profiles in the shortest time possible, and ensuring the maximum possible precision and accuracy in the results. - Increase the reliability of the analytical process, eliminating any possible errors in the identification ● and treatment of samples and products and in the revision and transcription of the results. - Reduce the risk of Operator contamination by minimizing interaction between the Operator and ● samples and products during the analytical process. To perform the operations for which it has been designed, QNext automatically follows the steps listed below: - Sample management: loading, positive identification, dilution (if required) and dispensation into cuvettes. - Reagent management: loading, positive identification, cooling, stirring, aspiration and dispensation into cuvettes. - Cuvette management: loading, transport, incubation during the reactions and management of used cuvettes. - Management of test requests. ● - Execution of test procedures. - Result management: optical measurement of the reactions, algorithm calculation of analytical parameters from reaction curves, validation of results, traceability, bi-directional transmission of requests and results to the LIS. - Management of disposable components. ● The data analyzed can be stored, displayed and printed. Additionally, the analyzer allows conducting integrated functions, such as the analysis of urgent samples or the Quality Control module. DG-PT consists of a glass vial containing lyophilized thromboplastin (tissue factor and phospholipids) from rabbit brain tissue, buffer, calcium ions and preservative. The closure system includes a stopper and a screw сар. DG-PT reagent is used to perform PT tests for: - the evaluation of the extrinsic and common coagulation pathways. - The monitoring Oral Anticoagulant Therapy with warfarin. The assay is based on the activation of the extrinsic coagulation pathway by the addition of the reagent to the plasma sample. The thromboplastin interacts with FVII and calcium ions activating a series of specific enzymes that comprise the extrinsic and common pathways of the coagulation cascade ultimately leading to the formation of a fibrin clot. The QNext reader measures the light change produced during the reaction.