Clinical Evaluation of the i-STAT ACTpro Cartridge in an Adult Population

Clinical Evaluation of the i-STAT ACTpro Cartridge Using Venous and Arterial Whole Blood Specimens on the i-STAT 1 Analyzer in an Adult Population

Measuring Activated Clotting Time (ACT) using the i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device.

The purpose of this study is to conduct a clinical evaluation of the investigational i-STAT ACTpro cartridge on the i-STAT 1 analyzer compared to a comparator device for measuring Activated Clotting Time (ACT) on venous and arterial whole blood specimens from adult participants.

The study will be conducted using whole blood specimens from participants undergoing Dialysis, Extracorporeal Life Support (ECLS)/ Extracorporeal Membrane Oxygenation (ECMO), and procedures in Electrophysiology Laboratories (EP Labs), Cardiac Catheterization Laboratories (Cath Labs), Interventional Radiology (IR) Units, and Cardiovascular Operating Rooms (CVOR).

Inclusion Criteria:

• Subject is prescribed unfractionated heparin (UFH) peri-procedurally in order to reduce the risk of blood clots.

OR

- Subject for which only the baseline specimen (prior to UFH administration) is collected, subject is admitted for a medical procedure that would or could typically necessitate the use of UFH to reduce the risk of blood clots.

Exclusion Criteria:

• Prior enrollment in the study.