Clinical Performance of the Investigational GEM Hemochron® 100 in Populations Ages 18 Years and Older

The study will be performed in the clinical setting by trained professional operators.

Group 1: Whole Blood Coagulation Test 1, GEM Hemochron® 100

Group 2: Whole Blood Coagulation Test 2, Hemochron® Signature Elite® 7000 Whole Blood
Microcoagulation System

Ex-vivo whole blood samples destined for discard after all medically directed tests are
complete will be used from heparinized patients undergoing standard of care interventional
procedures in different clinical settings. These include, but are not limited to, the
cardiovascular operating room (CVOR), cardiac catheterization lab, surgical intensive care
unit (SICU), the electrophysiology (EP) lab, and in extracorporeal membrane oxygenation
(ECMO) applications.

A distribution of ACT values is necessary to evaluate clinical accuracy. The target number of
subjects for each site is 100.

Samples will be examined at baseline (pre-heparin administration) and at the end of the
procedure. Heparinized samples may be obtained for ACT testing once or multiple times while
heparin is administered throughout the duration of the procedure. The frequency and time
intervals of ACT testing will be determined by the Standard of Care. No additional blood
volume or extra blood draws will occur as the result of this study.

The work flow for the testing process will be consistent across all sites. Expected duration
of the study is dependent upon the site logistics but generally is expected to last no more
than four to six weeks.

ACT results generated from the GEM Hemochron 100 instrument during this study will be used
solely for research purposes and will not be used for anticoagulation management of study
subjects. No patient follow up is required.

The study will include two GEM Hemochron 100 instruments, trained operators, and two
Signature Elite instruments for each procedure.

Guidance was obtained from Point-of-Care Monitoring of Anticoagulation Therapy; Approved
Guideline (CLSI POCT14-A), CLSI EP09-A3: "Method Procedure Comparison and Bias Estimation
Using Patient Samples; Approved guideline Third Edition" and peer reviewed literature.

All study data will be collected on Case Report Forms and all analysis will be performed by
Accriva.

Inclusion Criteria:

Therapeutic Group

Patients meeting all of the following criteria will be considered for entry into the study:

- Males and females 18 years or older.

- Patients scheduled for elective or urgent procedures requiring anticoagulation with
UFH.

- Patients requiring heparin anticoagulant therapy for any approved indication and being
managed and monitored with the ACT test.

Exclusion Criteria:

The following criteria define the population of subjects who will not be accepted in the
study:

- The subject develops a significant, unexpected, concurrent illness or adverse event
before the first whole blood sample is drawn.

- The subject with a hematocrit of less than 20% or greater than 55% since these samples
are not recommended for testing due to optical densities outside of the Hemochron
instrument levels of detection.