510(k) · Cleared

Cleared

FebriDx Bacterial/Non-bacterial Assay

K260787510(k) Dual TrackCleared Mar 24, 202614-day reviewClass II21 CFR 866.3230

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lumos Diagnostics, Inc. · QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

Cleared on Mar 24, 2026 as substantially equivalent to K230917 (Lumos Diagnostics, Inc., 2023) after a 14-day review. Its family tree reaches back 2 generations to 2019.

Decided: Mar 24, 2026
Review: 14 days
Class: Class II
Product code: QXA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to DEN180032 (2019). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN180032 Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha…Cd Diagnostics, Inc. · 2019
1 generation backK230917 FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc. · 2023
This deviceK260787 FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN180032	Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin…	Cd Diagnostics, Inc.	2019	—
−1	K230917	FebriDx Bacterial / Non-bacterial Point of Care Assay	Lumos Diagnostics, Inc.	2023	—
0 (this device)	K260787	FebriDx Bacterial/Non-bacterial Assay	Lumos Diagnostics, Inc.	2026	—

FIG. 1 — Lineage of K260787, 2019–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QXA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QXA device

#1 K230917 FebriDx Bacterial / Non-bacterial Point of…score 8.6 · 1 generation · no Class I recall

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K230917	FebriDx Bacterial / Non-bacterial Point of Care Assay Summary page 8 …K. Substantial Equivalence Information: 1. Predicate Device Name: FebriDx Bacterial / Non-bacterial Point-of-Care Assay 2. Predicate Number: K230917 510(k) Summary 3. Comparison with Predicate: K230917…	Lumos Diagnostics, Inc.	2023	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All QXA devices

QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · QXA

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QXA

Too few QXA 510(k)s in any year since 2007 to give a median.

Recalls per year · QXA

No recall names QXA since 2007.

Adverse event reports per year · QXA

No MAUDE report names QXA since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

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…

Read the full statement (166 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K260787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260787: FebriDx Bacterial/Non-bacterial Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260787

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026