DeviceClearance

FebriDx Bacterial/Non-bacterial Assay— 510(k) K260787

Substantially Equivalent

Lumos Diagnostics, Inc.

FDA 510(k) clearance K260787 for FebriDx Bacterial/Non-bacterial Assay, Substantially Equivalent on 2026-03-24. Applicant: Lumos Diagnostics, Inc.. Device class: 2.

Summary

Lumos Diagnostics' FebriDx Bacterial/Non-bacterial Assay is filed under QXA, lateral flow immunochromatography assays for host biomarkers of respiratory infection. The record doesn't describe the assay beyond its name and that code name.

Class II, 21 CFR 866.3230. Microbiology is both the classification panel and the review panel. The record lists the submission type as Dual Track.

Lumos Diagnostics filed from Carlsbad, California. Review took 14 calendar days (March 10 to March 24, 2026).

Clearance details

Applicant
Lumos Diagnostics, Inc.
Product code
Product code QXA
Device class
Class 2
Regulation
21 CFR 866.3230
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Dual Track
Location
Carlsbad, CA, US
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