510(k) · Cleared
ClearedFebriDx Bacterial / Non-bacterial Point of Care Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumos Diagnostics, Inc. · QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
Cleared on Jun 30, 2023 as substantially equivalent to DEN180032 (Cd Diagnostics, Inc., 2019) after an 88-day review. Its family tree reaches back 1 generation to 2019. 1 later device descends from it.
- Decided
- Jun 30, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- QXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180032 (2019). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN180032 Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha…Cd Diagnostics, Inc. · 2019
- This deviceK230917 FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260787 FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260787FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180032 | Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin… | Cd Diagnostics, Inc. | 2019 | — |
| 0 (this device) | K230917 | FebriDx Bacterial / Non-bacterial Point of Care Assay | Lumos Diagnostics, Inc. | 2023 | — |
| +1 | K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 K260787 FebriDx Bacterial/Non-bacterial Assayscore 11.4 · 2 generations · no Class I recall
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 | Decided |
|---|---|---|---|
| * | DEN180032 | Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow…Summary page 7…K. Substantial Equivalence Information: 1. Predicate Device Name: Synovasure Alpha Defensin Lateral Flow Test Kit 2. Predicate Number: DEN180032 3. Comparison with Predicate: Table 1. Comparison of FebriDx and Predicate Device… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260787 | FebriDx Bacterial/Non-bacterial Assay | 2026 | 0 |
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?
How does its category compare?
All QXA devicesQXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QXA
1in 2023
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The FebriDx Bacterial / Non-bacterial Point-of-Care 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 who present to urgent care or emergency care settings for evaluation of acute respiratory infection who have had symptoms for less than 7 days and…
Read the full statement (175 words)
The FebriDx Bacterial / Non-bacterial Point-of-Care 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 who present to urgent care or emergency care settings 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 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/K230917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230917: FebriDx Bacterial / Non-bacterial Point of Care Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230917
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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