Cleared Dual Track

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

Class II Microbiology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K260787 · Lumos Diagnostics, Inc. · Microbiology device
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Mar 2026
Decision
14d
Days
Class 2
Risk

K260787 is an FDA 510(k) clearance for the FebriDx Bacterial/Non-bacterial Assay. Classified as Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection (product code QXA), Class II - Special Controls.

Submitted by Lumos Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 24, 2026 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3230 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lumos Diagnostics, Inc. devices

Submission Details

510(k) Number K260787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2026
Decision Date March 24, 2026
Days to Decision 14 days
Submission Type Dual Track
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics

Device Classification

Product Code QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3230
Definition A Device To Detect And Measure Non-microbial Analytes To Aid In The Detection And Identification Of Localized Human Infections Is Identified As An In Vitro Device Intended For The Detection And Qualitative Measurement, Quantitative Measurement, Or Both Of One Or More Non-microbial Analytes In Human Clinical Specimens To Aid In The Assessment, Identification, Or Both Of A Localized Microbial Infection When Used In Conjunction With Clinical Signs And Symptoms And Other Clinical And Laboratory Findings.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.