FDA 510(k) Microbiology Devices

About Microbiology Devices

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