Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections

Food and Drug Administration, Department of Health and Human Services (HHS).

Final amendment; final order.

The Food and Drug Administration (FDA, the Agency, or we) is classifying the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

This order is effective May 9, 2025. The classification was applicable on May 23, 2019.