The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples 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 classification of the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples. We are taking this action because we have determined that classifying the device into class II 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.
US Federal Register - FDA Rules · June 22, 2026
FDA Classification of Simple In Vitro Diagnostic Device for Detection of Secreted Proteins From Bacillus Species in Human Clinical Samples as Class II
Original title: Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples
FDA classifies simple in vitro diagnostic devices for detection of secreted proteins from Bacillus species in human clinical samples into Class II with special controls.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.