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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
510(k) Number K262136
Device Name BIOFIRE SPOTFIRE Vaginitis (VG) Panel
Applicant
Biofire Diagnostics, LLC
515 Colorow Dr.
Salt Lake City,  UT  84108
Applicant Contact Erin Moseley
Correspondent
Biofire Diagnostics, LLC
515 Colorow Dr.
Salt Lake City,  UT  84108
Correspondent Contact Erin Moseley
Classification Product Code
PQA  
Subsequent Product Codes
NSU   OOI   OUY  
Date Received06/25/2026
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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