FDA Outlines Criteria on 510(k)s for Nucleic Acid Assays

Makers of enterovirus nucleic acid assays should demonstrate that the assay can detect all 64 serotypes associated with aseptic meningitis, according to a new FDA guidance. Released in conjunction with a Federal Register notice announcing the classification of enterovirus nucleic acid assays, the guidance discusses FDA recommendations for getting 510(k) clearance for the assays.
Devices & Diagnostics Letter