# K260787: FebriDx Bacterial/Non-bacterial Assay

- Pathway: 510(k) (Dual Track)
- Applicant: Lumos Diagnostics, Inc.
- Decided: Mar 24, 2026 after 14 days
- Product code: QXA (Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection)
- Device class: 2
- Regulation: 21 CFR 866.3230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180032 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230917: FebriDx Bacterial / Non-bacterial Point of Care Assay, Lumos Diagnostics, Inc. (2023) Summary page 8.

## Indications for use
The FebriDx Bacterial/Non-bacterial Assay is a qualitative visually read rapid immunoassay for the detection of human host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) directly from fingerstick blood. FebriDx is indicated for use in patients aged 12-64 for evaluation of acute respiratory infection who have had symptoms for less than 7 days and within 3 days of fever onset. FebriDx test results are intended to be used in conjunction with other clinical and diagnostic findings as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology. The assessment of whether a bacterial infection is present should always be based on consideration of all available information, and not based solely on the FebridDx test results. FebriDx test results are not intended to identify a specific pathogen or the severity of infection. FebriDx External Controls: FebriDx External Controls are used in the FebriDx Test as assayed quality control samples to assess the performance and reliability of the FebriDx Test.

Source page: https://510kreport.com/device/K260787
Methodology: https://510kreport.com/methodology