Identifiers
- 510(k) Number
- K012371 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 is an in vitro diagnostic reagent system classified as an Antigen, Antiserum, Control, and Transferrin assay. It is designed for the quantitative measurement of transferrin concentrations in human serum and plasma, as well as in urine, using Roche/Hitachi cobas c systems. Transferrin is a glycoprotein that binds iron and plays a key role in iron transport and storage within the body. This assay provides a means to evaluate iron metabolism and diagnose conditions related to iron deficiency or overload.
This device is supplied as a reagent system intended for use on Roche/Hitachi cobas c systems, including models such as cobas c 503 and cobas c 311. It is intended for single-use in clinical laboratory settings and requires no special sterility beyond standard in vitro diagnostic reagent handling. The device holds an FDA 510(k) clearance (K012371) under the classification of Class II medical devices, adhering to regulatory standards for in vitro diagnostics. Storage and handling follow standard laboratory protocols for reagent systems, ensuring stability and accuracy of results.
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 (K012393) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012371 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K012371 24 fields · synced Sep 20, 2026