FDA classifies rapid test for Bacillus proteins as Class II device
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The Food and Drug Administration has officially classified a specific type of diagnostic test into Class II. The device is designed to detect secreted proteins from Bacillus species in human clinical samples. This classification covers tests that presumptively identify the bacteria responsible for anthrax and other related infections.
Why it matters: This action lowers the regulatory hurdle for manufacturers of this specific type of rapid test. Class II devices generally face less stringent review than Class III devices, which require premarket approval. This change allows manufacturers to bring these diagnostic tools to market more efficiently while maintaining safety through special controls like labeling requirements and performance verification.
Who it affects
- Manufacturers of in vitro diagnostic tests for Bacillus species
This final order was issued by the Food and Drug Administration, which is part of the Department of Health and Human Services. You should check the original Federal Register document for full details on the special controls and labeling requirements before relying on this information.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document