FDA.reportPublic FDA data

510(k) K262136

Device
BIOFIRE SPOTFIRE Vaginitis (VG) Panel
Applicant
Biofire Diagnostics, LLC
510(k) number
K262136
Product code
PQA
Decision
Substantially Equivalent (SESE)
Decision date
2026-10-21
Date received
2026-06-25
Regulation
866.3975
Classification name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Dual Track
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Erin Moseley
Address
515 Colorow Dr. Salt Lake City UT US 84108 84108

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PQA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260021cobas® BV/CVRoche Molecular Systems, Inc.2026-07-16
K243725BD Vaginal PanelBecton, Dickinson and Company2024-12-19
K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.2024-11-25
K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid2023-10-19
K223653BD Vaginal PanelBecton, Dickinson and Company2023-03-06
K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid2022-06-07
K212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid2022-02-09
K201017BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences)2021-10-18
K191957BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics)2019-10-21
K190452Aptima BV AssayHologic, Inc.2019-05-23
K190472Aptima CV/TV AssayHologic, Inc.2019-05-16
DEN160001BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)2016-10-28