Microbiology— FDA advisory panel MI

The microbiology panel is infectious-disease diagnostics: culture media and automated culture systems, organism identification and antimicrobial susceptibility platforms, rapid antigen tests, and the nucleic-acid amplification assays that have steadily displaced culture for many targets. Its product-code count is among the highest of any panel because codes are largely organized per pathogen or pathogen family — each new cleared target adds another code to the map.

Two reading notes. Molecular multiplexing blurs the one-code-one-test assumption: a single cleared panel assay may detect a dozen organisms and reference several codes. And public-health events distort the time series — emergency-authorized tests (EUAs) never appear in 510(k) data at all, then arrive years later as a delayed wave when manufacturers convert authorizations into standard clearances. Treat volume dips and spikes here with that lag in mind.