K260787 is an FDA 510(k) clearance for the FebriDx Bacterial/Non-bacterial 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 March 24, 2026, 14 days after receiving the submission on March 10, 2026.
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..
| 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 |
| 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. |