Medical devices; immunology and microbiology devices; classification of the beta-glucan serological assay. Final rule.
The Food and Drug Administration (FDA) is classifying the beta-glucan serological reagent device 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: Serological Assays for the Detection of Beta-Glucan." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. 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 publishing a notice of availability of a guidance document that is the special control for this device.
D000946:Antigens, Fungal / Q000097:blood / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence; D010450:Endopeptidases / Q000097:blood / Q000145:classification; D004867:Equipment Design; D004869:Equipment Safety; D005936:Glucans / Q000097:blood / Q000145:classification*; D006801:Humans; D007118:Immunoassay / Q000145:classification / Q000295:instrumentation; D009181:Mycoses / Q000097:blood*; D012698:Serologic Tests / Q000145:classification* / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration
D000946:Antigens, Fungal; D005936:Glucans; D010450:Endopeptidases