Cleared Traditional

K230917 - FebriDx Bacterial / Non-bacterial Point of Care Assay (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence.

K230917 · Lumos Diagnostics, Inc. · Microbiology device
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Jun 2023
Decision
88d
Days
Class 2
Risk

K230917 is an FDA 510(k) clearance for the FebriDx Bacterial / Non-bacterial Point of Care 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 June 30, 2023 after a review of 88 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 K230917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2023
Decision Date June 30, 2023
Days to Decision 88 days
Submission Type Traditional
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
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02018198 Completed Observational Industry-sponsored

FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test

DIStinguish Respiratory Underlying Pathogen associaTed Host Response in Acute Respiratory Infection: An Evaluation of FebriDx POC Test

540
Patients (actual)
20
Sites
Condition studied Acute Respiratory Tract Infections
Eligibility All sexes · 1 Year+ · Healthy volunteers accepted
Principal investigator Nathan Shapiro, MD
Sponsor Rapid Pathogen Screening (industry)
Started 2019-10-15 → Primary completion 2021-04-30 → Completed 2021-06-10
Primary outcome
The primary outcome is the presence of a bacterial associated systemic host immune response or viral associated systemic host immune response related to an acute community acquired febrile acute respiratory tract infection, as compared to final diagnosis
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov