Tina-quant Transferrin ver.2 (Urine Application)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182095 FDA 510(k)
- FDA Product Code
- DDG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5880 FDA 510(k)
- Regulation Number
- 866.5880 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tina-quant Transferrin ver.2 (Urine Application) is an in vitro diagnostic device for the quantitative immunological determination of human transferrin in urine. Transferrin is an iron-binding and transporting protein, and its measurement in urine aids in diagnostic evaluations related to protein metabolism and renal function.
This assay is designed for use on Roche/Hitachi cobas c systems and is supplied as a reagent kit. The device is intended for single-use in clinical laboratory settings, with no regulatory indication of sterility or MRI safety requirements specified. Authorised under FDA 510(k) clearance (K182095), it falls under the classification of Class II medical devices (device class 2) and is governed by regulation number 866.5880.
Frequently asked questions
What clinical applications does the Tina-quant Transferrin ver.2 (urine application) support in patient evaluation?
This device quantifies human transferrin in urine, aiding diagnostic evaluations related to protein metabolism and renal function. Transferrin levels in urine can help assess conditions affecting iron transport and kidney health, such as proteinuria or renal tubular disorders.
How is the Tina-quant Transferrin ver.2 (urine application) supplied, and is it intended for single-use?
The device is supplied as a reagent kit designed exclusively for single-use in clinical laboratory settings. It is not intended for reuse or repeated applications, ensuring consistency and safety in diagnostic testing.
Which Roche/Hitachi cobas c systems is this assay compatible with, and does it require special handling for sterility?
The Tina-quant Transferrin ver.2 (urine application) is engineered for use on Roche/Hitachi cobas c systems. While it is intended for laboratory use, the data does not specify any regulatory sterility requirements, meaning it is not classified as a sterile device.
What regulatory pathway was followed for FDA clearance, and what device class does it belong to?
The Tina-quant Transferrin ver.2 (urine application) received FDA clearance through a traditional 510(k) pathway, specifically under K182095, and is classified as a Class II medical device. This classification reflects its moderate risk level, governed by regulation number 866.5880.
Are there any special storage requirements mentioned for this reagent kit?
The provided data does not specify storage conditions for the Tina-quant Transferrin ver.2 (urine application) reagent kit. However, as with most diagnostic reagents, adherence to manufacturer guidelines (e.g., temperature, light exposure) is recommended to maintain accuracy and stability.
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: TRSF2, Tina-quant Transferrin ver.2 - Roche Diagnostics USA, TRSF2, Tina-quant Transferrin ver.2 - Roche Diagnostics USA, Tina-quant Transferrin ver.2 (urine application)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182095 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Operations (Rdo)
Sources (1)
- FDA 510(k) K182095 24 fields · synced Sep 19, 2026