FDA 510(k) Microbiology Devices

FDA 510(k) Microbiology Devices - Regulatory Overview

FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.

Key device types:

• Blood culture systems - automated incubation and detection platforms
• Microbial identification - MALDI-TOF, biochemical and molecular ID systems
• Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
• Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
• Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens