Application of the Rules - Flow Diagram Part 2

Use with respect to Transmissible Agents

Rule 1

An IVDD used for donor screening to detect transmissible agents is Class IV.

Rule 2

An IVDD used to determine disease or immune status from transmissible agents is Class II unless:

• It is used for detection of HIV, HTLV, HBV, HCV or HDV - then it is a Class IV;
• It is used to determine disease or immune status for transmissible agents that cause a serious disease where there is a risk of propagation in the Canadian population (M. Tuberculosis, agents causing nosocomial infections) - then it is Class III;
• It detects presence of/exposure to sexually transmitted agents - then it is Class III;
• There is risk an erroneous result would cause death or severe disability (prenatal, neonatal screening) - then it is Class III;
• It detects agents in the blood/CSF - then it is Class III.

Rule 3

An IVDD used to detect transmissible agents for patient management is Class II unless:

• It is used for management of Patients suffering from a life-threatening disease (ie HIV, Hepatitis), then it is Class III;
• An erroneous result would lead to patient management decisions resulting in an imminent life threatening situation, and then it is Class III.