Cleared Traditional

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

K230917 · Lumos Diagnostics, Inc. · Microbiology device
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. This device is classified as a Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection (Class II - Special Controls, product code QXA).

Submitted by Lumos Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 30, 2023, 88 days after receiving the submission on April 3, 2023.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3230. 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..

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

Device Classification

Product Code QXA - Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
Device Class Class II - 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.