title: Medical devices; clinical chemistry and clinical toxicology devices; classification of hemoglobin A1c test system. Final order.
abstract: The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test system classification. 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.
mesh_terms: D001774:Blood Chemical Analysis / Q000145:classification* / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D003920:Diabetes Mellitus / Q000097:blood; D006442:Glycated Hemoglobin / Q000737:chemistry*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D006442:Glycated Hemoglobin