De Novo · Granted
GrantedSynovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cd Diagnostics, Inc. · QGN Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
Granted on May 23, 2019 as a new device type through De Novo after a 328-day review. 3 later devices descend from it.
- Decided
- May 23, 2019
- Review
- 328 days
- Class
- Class II
- Product code
- QGN
- Recalls
- None
3 later devices descend from it, 2 citing it directly.
- This deviceDEN180032 Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha…Cd Diagnostics, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK230917 FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK260787 FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK212204 Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure…Cd Diagnostics, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K230917FebriDx Bacterial / Non-bacterial Point of Care AssayLumos Diagnostics, Inc. · 2023 · cites it directly1descendant
- K260787FebriDx Bacterial/Non-bacterial AssayLumos Diagnostics, Inc. · 2026 · 2 generations on0descendants
- K212204Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin…Cd Diagnostics, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | 2026 | — |
| +1 | K212204 | Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha… | Cd Diagnostics, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 QGN? 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 QGN device
- #1 K212204 Synovasure Alpha Defensin Lateral Flow Test…score 1.8 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K230917 (Lumos Diagnostics, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QGN devicesQGN Lateral Flow Immunochromatography Assay For Host Infection Biomarkers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QGN
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QGN
Too few QGN 510(k)s in any year since 2007 to give a median.
Recalls per year · QGN
No recall names QGN since 2007.
Adverse event reports per year · QGN
No MAUDE report names QGN 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 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synovasure Alpha Defensin Lateral Flow Test Kit is a qualitative visually read immunochromatographic assay for the detection of human host response proteins, Alpha Defensins 1-3, in the synovial fluid of adults with a total joint replacement who are being evaluated for revision surgery. The Synovasure Alpha Defensin Lateral Flow Test Kit results are intended to be used in conjunction with other clinical and diagnostic findings as an aid in the…
Read the full statement (133 words)
The Synovasure Alpha Defensin Lateral Flow Test Kit is a qualitative visually read immunochromatographic assay for the detection of human host response proteins, Alpha Defensins 1-3, in the synovial fluid of adults with a total joint replacement who are being evaluated for revision surgery. The Synovasure Alpha Defensin Lateral Flow Test Kit results are intended to be used in conjunction with other clinical and diagnostic findings as an aid in the diagnosis of periprosthetic joint infection (PJI). The Synovasure Alpha Defensin Lateral Flow Test Kit is not intended to identify the etiology or severity of a PJI.
The Synovasure Alpha Defensin Control Kit is used in the Synovasure Alpha Defensin Lateral Flow Test Kit as assayed quality control samples to monitor performance and reliability of the Synovasure Alpha Defensin Lateral Flow Test Kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180032 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180032: Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180032
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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