2024-18264. Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness

Table 1—Device To Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness Risks and Mitigation Measures

Identified risks	Mitigation measures
Risk of an inaccurate test result (false positive or false negative result) leading to improper patient management	Certain labeling information, including certain limiting statements and performance information; Certain design verification and validation, including certain analytical studies and clinical studies; and Use of certain specimen collection devices.
Misinterpretation of test results leading to misdiagnosis and associated risk of false test results	Certain labeling information, including certain limiting statements and performance information; and Certain design verification and validation, including certain analytical studies and clinical studies.
Failure to correctly operate the device leading to inaccurate test results	Certain labeling information, including certain limiting statements and performance information; Certain design verification and validation, including certain analytical studies and clinical studies; and Use of certain specimen collection devices.