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Uryxxon Relax Urine Analyzer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K061742

by MACHEREY-NAGEL GmbH & Co. KG

Identifiers

510(k) Number
K061742 FDA 510(k)
FDA Product Code
JIL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1340 FDA 510(k)
Regulation Number
862.1340 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Urxxon Relax Urine Analyzer is an enzymatic, non-quantitative method for detecting urinary glucose. Classified under Clinical Chemistry, this device performs qualitative analysis of urine samples to identify the presence of glucose without quantifying its concentration.

This analyzer is intended for single-use in clinical chemistry laboratories and is supplied as a ready-to-use test system. It is not designed for MRI environments and requires proper storage as per manufacturer instructions. Authorized under FDA 510(k) clearance and IVDR compliance, the device adheres to regulatory standards for in vitro diagnostics, ensuring reliability for diagnostic purposes.

Frequently asked questions

What is the Urxxon Relax Urine Analyzer used for in clinical settings?

The Urxxon Relax Urine Analyzer is an enzymatic, non-quantitative device designed specifically for detecting the presence of glucose in urine samples. It performs qualitative analysis, meaning it identifies whether glucose is present but does not measure its concentration. This makes it useful in clinical chemistry laboratories for screening or confirming urinary glucose levels, which can be relevant for diagnosing conditions like diabetes.

Is the Urxxon Relax Urine Analyzer intended for repeated use, or is it single-use only?

The Urxxon Relax Urine Analyzer is explicitly designed for single-use in clinical chemistry laboratories. This means each test system is meant to be used once and then discarded, ensuring hygiene and preventing cross-contamination between patients.

How is the Urxxon Relax Urine Analyzer supplied, and what does a ready-to-use test system include?

The Urxxon Relax Urine Analyzer is supplied as a ready-to-use test system, meaning no additional preparation or reagents are required beyond what is provided. The system is pre-packaged for immediate use in clinical settings, simplifying workflow and reducing the risk of user error during setup.

Are there any special storage requirements for the Urxxon Relax Urine Analyzer, and can it be used in an MRI environment?

The device requires proper storage as per the manufacturer’s instructions, though specific conditions (e.g., temperature, humidity) are not detailed in the provided data. Importantly, it is not designed for use in MRI environments, so it should not be used or stored where magnetic fields are present.

What regulatory pathways has the Urxxon Relax Urine Analyzer followed, and what does this mean for its use?

The Urxxon Relax Urine Analyzer has been authorized under FDA 510(k) clearance and complies with the In Vitro Diagnostic Regulation (IVDR). This means it has undergone review by the FDA to demonstrate substantial equivalence to a predicate device and meets EU regulatory standards for safety, performance, and clinical accuracy. Clinicians can rely on its compliance with these frameworks for reliable diagnostic use in clinical chemistry.

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

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
MACHEREY-NAGEL GmbH & Co. KG

Sources (2)

  • FDA 510(k) K061742 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026