Modification to Roche Diagnostics Tina-quant Rheumatoid Factors II Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032535 FDA 510(k)
- FDA Product Code
- DHR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5775 FDA 510(k)
- Regulation Number
- 866.5775 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Modification to Roche Diagnostics Tina-quant Rheumatoid Factors II Test System is an immunological test system that measures rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues using immunochemical techniques. This device is classified as a System, Test, Rheumatoid Factor with product code DHR.
The modification to the Roche Diagnostics Tina-quant Rheumatoid Factors II Test System is a Class II device under special controls, as determined by the FDA 510(k) clearance K032535. It was submitted by Roche Diagnostics Corp. and received FDA clearance on September 10, 2003, as substantially equivalent. The device is intended for use in immunology testing applications.
Frequently asked questions
What is the Modification to Roche Tinaquant Rheumatoid Factors II Test System used for?
It is an immunological test system designed to measure rheumatoid factor, which are antibodies to immunoglobulins, in serum, other body fluids, and tissues. The measurement is performed using immunochemical techniques to support immunology testing applications.
How is the Modification to Roche Tinaquant Rheumatoid Factors II Test System supplied or configured?
The device is supplied as a complete test system, including reagents and calibrators necessary for performing the immunochemical assay. It is intended for use with compatible instrumentation as part of the Tina-quant platform for quantitative rheumatoid factor detection.
Is the Modification to Roche Tinaquant Rheumatoid Factors II Test System sterile or single-use?
The device data does not specify sterility or single-use status. As an in vitro diagnostic test system, it typically includes liquid reagents and calibrators that are not sterile but are intended for single use in testing procedures to avoid cross-contamination.
What sizes or models are available for the Modification to Roche Tinaquant Rheumatoid Factors II Test System?
The device data does not list specific sizes, models, or reference numbers beyond the system name. It is identified as a modification to the Tina-quant Rheumatoid Factors II Test System under the manufacturer’s product line, with no additional variants detailed in the provided information.
What regulatory pathway was used for the Modification to Roche Tinaquant Rheumatoid Factors II Test System?
The device received FDA 510(k) clearance under submission number K032535 on September 10, 2003. It was determined to be substantially equivalent to a predicate device and is classified as a Class II device under special controls, with product code DHR for immunology applications.
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: Modification To:Roche Diagnostics Tina-quant Rheumatoid Factors Ii Test ..., K032535 FDA 510(k) - MODIFICATION TO:ROCHE DIAGNOSTICS TINA-..., MODIFICATION TO:ROCHE… — K032535 · DeviceClearance, K032535 FDA 510(k) - MODIFICATION TO:ROCHE DIAGNOSTICS TINA-...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032535 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K032535 24 fields · synced Sep 21, 2026