Identifiers
- 510(k) Number
- K961277 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 RF IgM ELISA Test System is an in vitro diagnostic device classified as an Enzyme-Linked Immunosorbent Assay (ELISA) System for the qualitative and semi-quantitative detection of rheumatoid factor (RF) IgM-class antibodies in human serum. It functions by utilizing immunoassay principles to measure antibody levels, aiding in the diagnostic evaluation of rheumatoid arthritis.
This system is supplied as a kit for laboratory use and is intended for single-use per test. It requires no special storage conditions beyond standard laboratory practices and is not designed for MRI compatibility. The device holds an FDA 510(k) clearance (K961277) under the classification of Class II (DHR) and is regulated under 21 CFR 866.5775. No third-party certification is indicated, and the system is intended exclusively for professional in vitro diagnostic use.
Frequently asked questions
What is the RF IgM ELISA Test System used for?
The RF IgM ELISA Test System is designed for the qualitative and semi-quantitative detection of rheumatoid factor (RF) IgM-class antibodies in human serum. It aids in the diagnostic evaluation of rheumatoid arthritis by measuring antibody levels through immunoassay principles, helping clinicians assess potential autoimmune conditions.
How is the RF IgM ELISA Test System supplied, and is it for single-use?
The RF IgM ELISA Test System is supplied as a kit intended exclusively for laboratory use. Each test within the kit is designed for single-use only, ensuring accuracy and preventing cross-contamination between samples.
What storage conditions are required for the RF IgM ELISA Test System?
The system requires no special storage conditions beyond standard laboratory practices. This means it can be stored under typical lab temperature and humidity conditions, as long as it is protected from extreme environments or contamination.
Is the RF IgM ELISA Test System reusable, or is it intended for single-use?
The RF IgM ELISA Test System is explicitly intended for single-use per test. This design ensures reliability and reduces the risk of carryover or contamination between tests, which is critical for accurate diagnostic results.
Does the RF IgM ELISA Test System have any regulatory approvals or certifications?
The RF IgM ELISA Test System holds an FDA 510(k) clearance (K961277) under the classification of Class II (DHR) and is regulated under 21 CFR 866.5775. No third-party certification is indicated, and it is intended exclusively for professional in vitro diagnostic use.
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: RF IgM Test System - ZEUS Scientific, PDF RF IgM Test System, RF IGM ELISA TEST SYSTEM (K961277) — FDA 510 (k) | Innolitics, ELISA RF IgM Test Sytem - BEUDAMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961277 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K961277 24 fields · synced Oct 1, 2026