DUS R-50S Urine Chemistry System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Dfi Co., Ltd
Identifiers
- 510(k) Number
- K171521 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 DUS R-50S Urine Chemistry System is a Method, Enzymatic, Glucose (Urinary, Non-Quantitative) device, classified under Clinical Chemistry. It performs non-quantitative enzymatic analysis of urine samples to detect the presence of glucose and other biochemical markers, aiding in the diagnostic evaluation of metabolic and renal conditions.
This system is designed for in vitro use in clinical laboratory settings, supplied as a reusable instrument with single-use test strips or reagents. It operates under FDA 510(k) clearance (K171521) and IVDR compliance, adhering to regulatory standards for urine chemistry testing. Storage and handling follow manufacturer guidelines to maintain accuracy and sterility, with no MRI safety restrictions specified.
Frequently asked questions
What types of biochemical markers can the DUS R-50S Urine Chemistry System detect in urine samples?
The DUS R-50S Urine Chemistry System performs non-quantitative enzymatic analysis specifically for glucose in urine samples. While the primary focus is glucose detection, the system is designed to aid in the diagnostic evaluation of metabolic and renal conditions, which may involve other biochemical markers as part of broader clinical chemistry testing. However, the exact markers beyond glucose are not detailed in the provided data.
Is the DUS R-50S Urine Chemistry System reusable or single-use, and how are the test components supplied?
The DUS R-50S itself is a reusable instrument, but it operates using single-use test strips or reagents. This design ensures sterility and accuracy for each test while allowing the main device to be used repeatedly across multiple tests in a clinical laboratory setting.
What regulatory pathways has the DUS R-50S Urine Chemistry System followed, and what does that mean for its use?
The system has undergone FDA 510(k) clearance (K171521) and is compliant with the In Vitro Diagnostic Regulation (IVDR). This means it has been evaluated for safety, performance, and equivalence to existing devices, allowing it to be legally marketed and used in clinical laboratories for urine chemistry testing under these regulatory frameworks.
Are there any special storage requirements for the DUS R-50S Urine Chemistry System or its single-use components?
While the exact storage conditions aren’t specified in the provided data, the manufacturer’s guidelines (referenced in the description) must be followed to maintain accuracy and sterility. This typically includes protecting the reusable instrument from contamination, moisture, and extreme temperatures, as well as ensuring single-use test strips are stored properly to preserve their integrity before use.
Does the DUS R-50S Urine Chemistry System have any limitations regarding its use in specific environments, like MRI compatibility?
The provided data does not mention any MRI safety restrictions for the DUS R-50S Urine Chemistry System. However, since it is a reusable clinical instrument, standard laboratory safety protocols (e.g., electrical safety, electromagnetic interference) should still be followed to ensure proper operation in any clinical setting.
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 | K171521 | Class II | Active |
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Manufacturer
- Manufacturer
- Dfi Co., Ltd
- FDA Applicant
- DFI Co., Ltd.
Sources (2)
- FDA 510(k) K171521 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026