FDA Reclassifies Influenza Test Systems as Class II

The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing.

There is evidence that the currently available antigen-based RIDTs, which are widely used in non-clinical laboratory settings, are performing poorly, resulting in many misdiagnosed cases, the agency said.

In addition to requiring premarket notification, the final order requires special controls that:

• Identify the minimum acceptable performance criteria;
• Require use of an FDA-accepted comparator method for establishing the performance of new antigen based RIDTs;
• Require annual analytical reactivity testing of contemporary influenza strains; and
• Require analytical reactivity testing of newly emerging strains under certain situations involving an emergency or potential for an emergency. — Jeff Kinney