Medical devices; immunology and microbiology devices; classification of Plasmodium species antigen detection assays. Final rule.
The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
D000818:Animals; D000953:Antigens, Protozoan / Q000097:blood*; D006801:Humans; D007159:Immunologic Tests / Q000145:classification* / Q000295:instrumentation; D008828:Microbiological Techniques / Q000145:classification*; D010961:Plasmodium / Q000276:immunology* / Q000382:microbiology; D014481:United States; D014486:United States Food and Drug Administration
D000953:Antigens, Protozoan