Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EAS…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220046 FDA 510(k)
- FDA Product Code
- DJG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Superbio Fentanyl Urine Detection Kit with Immunofluorescence Analyzer EASY-11 is an enzyme immunoassay device designed for the qualitative detection of fentanyl in urine samples. It employs immunofluorescence technology to identify fentanyl metabolites, aiding in clinical toxicology assessments for suspected opioid exposure or overdose cases.
This device is intended for single-use in clinical laboratory settings and requires no special sterility conditions beyond standard aseptic handling. The Immunofluorescence Analyzer EASY-11 is a Class II (moderate-risk) device under FDA regulations, with FDA 510K clearance and IVDR compliance. It operates without MRI restrictions and is supplied as a kit containing all necessary reagents and controls for immediate use upon reconstitution. Authorisations include the registration numbers 3010934853 and 3031697086 among others, adhering to the 862.3650 regulatory framework.
Frequently asked questions
What clinical setting is the Superbio Fentanyl Urine Detection Kit designed for, and how does it differ from standard toxicology testing?
The Superbio Fentanyl Urine Detection Kit is specifically designed for clinical laboratory settings to qualitatively detect fentanyl metabolites in urine samples using immunofluorescence technology. Unlike general toxicology screens, this kit is tailored for suspected opioid exposure or overdose cases, providing rapid results to aid in clinical toxicology assessments. It is not intended for point-of-care or emergency room use outside of a lab environment.
Is the Immunofluorescence Analyzer EASY-11 compatible with MRI environments, and what are its primary use restrictions?
The Immunofluorescence Analyzer EASY-11 is not restricted for use in MRI environments, meaning it can be safely operated near MRI machines without interference. However, its primary restriction lies in its clinical laboratory setting designation, as it is not intended for bedside or non-laboratory use. It is also a single-use device, requiring proper disposal after each test.
How is the Superbio Fentanyl Urine Detection Kit supplied, and what preparation is required before use?
The kit is supplied as a complete, ready-to-use system, containing all necessary reagents and controls. No additional sterilization or special handling is required beyond standard aseptic practices—the device is designed for single-use and does not require reconstitution beyond following the manufacturer’s instructions for sample application. It is intended for immediate use upon receipt, provided storage conditions (e.g., refrigeration if applicable) are maintained.
What regulatory pathways does the Superbio Fentanyl Urine Detection Kit follow, and how does this affect its availability?
The kit follows FDA 510(k) clearance and IVDR compliance, meaning it has undergone regulatory review for safety and performance in the U.S. and EU markets. This clearance confirms its substantial equivalence to predicate devices in the Clinical Toxicology category (per FDA’s 862.3650 framework). Availability depends on local regulatory approvals, but the manufacturer’s registration numbers (e.g., 3010934853) indicate compliance with both U.S. and EU requirements, ensuring distribution through licensed clinical laboratories.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220046 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superbio Technology Co., Ltd.
Sources (2)
- FDA 510(k) K220046 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026