Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Late…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN180032 FDA 510(k)
- FDA Product Code
- QGN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3230 FDA 510(k)
- Regulation Number
- 866.3230 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Synovasure Alpha Defensin Lateral Flow Test Kit is a lateral flow immunochromatography assay designed for the qualitative detection of human alpha defensins 1-3 in synovial fluid. It functions as a rapid, visually read diagnostic tool to identify host infection biomarkers, aiding in the evaluation of joint replacement patients for potential revision surgery.
This device is supplied in single-use formats (5, 10, or 30 tests) and includes a control kit for validation. It is intended for use in clinical microbiology settings and has received FDA 510(k) clearance under classification II (QGN product code). The test requires no specialized equipment beyond standard laboratory facilities and provides results within 10 minutes.
Frequently asked questions
What types of samples can the Synovasure Alpha Defensin Lateral Flow Test Kit analyze, and how quickly can results be obtained?
The Synovasure Alpha Defensin Lateral Flow Test Kit is specifically designed for qualitative detection of human alpha defensins 1-3 in synovial fluid only. Results are visually interpreted within 10 minutes after sample application, making it a rapid diagnostic tool for evaluating joint replacement patients.
Are the test kits single-use, and if so, what package sizes are available for purchase?
Yes, the Synovasure Alpha Defensin Lateral Flow Test Kit is single-use per test. It is supplied in convenient multi-test formats to accommodate clinical workflows: 5-test, 10-test, or 30-test kits, along with a separate Synovasure Alpha Defensin Control Kit for validation purposes.
Does this test require specialized equipment, and what clinical setting is it intended for?
No specialized equipment is needed beyond standard laboratory facilities. The test is designed for clinical microbiology settings, particularly for use in evaluating joint replacement patients to identify infection biomarkers via synovial fluid analysis.
How is the regulatory status of this device, and what does the FDA 510(k) clearance mean for its use?
The Synovasure Alpha Defensin Lateral Flow Test Kit holds FDA 510(k) clearance under classification II, meaning it has been determined to be substantially equivalent to a legally marketed device. This clearance allows for its use in clinical settings as described, specifically for qualitative detection of alpha defensins in synovial fluid to aid in infection evaluation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Synovasure® Alpha Defensin Lateral Flow Test | Zimmer Biomet, PDF Synovasure® Alpha Defensin Lateral Flow Test - Zimmer Biomet, PDF Also available as Qty 1 (REF 00-8888-125-01). Check local availability ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN180032 | Class II | Active |
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Manufacturer
- Manufacturer
- Cd Diagnostics, Inc.
Sources (1)
- FDA 510(k) DEN180032 24 fields · synced Sep 19, 2026