2024-18266. Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens

Table 1—Device To Detect and Identify Nucleic Acid Targets in Respiratory Specimens From Microbial Agents That Cause the SARS-CoV-2 Respiratory Infection and Other Microbial Agents When in a Multi-Target Test 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 limitations, warnings, device descriptions, explanation of procedures, and performance information identified in special controls (1), (3), (5), and (6); Use of certain specimen collection devices identified in special control (2); Certain design verification and validation, documentation of certain analytical studies and clinical studies, risk analysis strategies, and device descriptions identified in special control (4); and Testing of characterized viral samples and labeling information identified in special control (7).
Misinterpretation of test results leading to misdiagnosis and associated risk of false test results	Certain labeling information, including limitations, warnings, device descriptions, explanation of procedures, results interpretation information, and performance information identified in special controls (1), (3), and (5); Certain design verification and validation, documentation of certain analytical studies and clinical studies, risk analysis strategies, and device descriptions identified in special control (4).
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Failure to correctly operate the device leading to inaccurate test results	Certain labeling information, including limitations, warnings, device descriptions, explanation of procedures, and performance information identified in special controls (1), (3), (5), and (6); Use of certain specimen collection devices identified in special control (2); and Certain design verification and validation, documentation of certain analytical studies and clinical studies, risk analysis strategies, and device descriptions identified in special control (4).