The FDA is classifying reagents for the detection of special novel influenza A viruses in Class II (special controls). Special controls that will apply to the device are in the guidance document, "Class II Special controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses."
The FDA is classifying the device into Class II in order to provide reasonable assurance of safety and effectiveness of the device. The rule becomes effective April 21, 2006. Devices not in commercial distribution before 1976 are classified automatically by statute in Class III without any FDA rulemaking process. They remain Class III unless reclassified after premarket approval.
For more information on the final rule visit http://www.fda.gov/OHRMS/DOCKETS/98fr/06-2742.htm (http://www.fda.gov/OHRMS/DOCKETS/98fr/06-2742.htm).