2024-21086. Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management

Table 1—Quantitative Viral Nucleic Acid Test for Transplant Patient Management Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Risk of false results	Certain warnings, limitations, results interpretation information, and explanation of procedures in labeling; and Certain device descriptions and specifications, analytical studies, clinical studies, and risk analysis in design verification and validation.
Failure to correctly interpret test results	Certain warnings, limitations, results interpretation information, and explanation of procedures in labeling.
Failure to correctly operate the device	Certain warnings, limitations, results interpretation information, and explanation of procedures in labeling.