# 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

- Pathway: De Novo (Direct)
- Applicant: Cd Diagnostics, Inc.
- Decided: May 23, 2019 after 328 days
- Product code: QGN (Lateral Flow Immunochromatography Assay For Host Infection Biomarkers)
- 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K230917: FebriDx Bacterial / Non-bacterial Point of Care Assay (2023), 1 descendant of its own
- K260787: FebriDx Bacterial/Non-bacterial Assay (2026), 0 descendants of its own
- K212204: Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN180032
Methodology: https://510kreport.com/methodology