Identifiers
- 510(k) Number
- K993213 FDA 510(k)
- FDA Product Code
- CFF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5510 FDA 510(k)
- Regulation Number
- 866.5510 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The K-Assay IgA is an immunoturbidimetric assay reagent designed for the quantitative determination of human IgA in serum. It is intended for use on automated chemistry analyzers to measure immunoglobulin A levels.
This liquid reagent is supplied as a kit and is regulated under FDA 510(k) clearance. It is classified as an immunoelectrophoretic immunoglobulin device for use in clinical settings.
Frequently asked questions
What is the primary clinical use of the K-ASSAY IgA?
The K-ASSAY IgA is designed for the quantitative determination of human immunoglobulin A (IgA) levels in serum samples. It is intended for use in clinical settings to measure IgA concentrations using automated chemistry analyzers.
How is the K-ASSAY IgA reagent supplied?
The product is supplied as a liquid reagent kit. It is specifically formulated for integration into automated chemistry analyzer workflows to facilitate efficient laboratory testing.
What is the regulatory status of this device?
The K-ASSAY IgA is regulated under FDA 510(k) clearance, specifically under the K993213 submission. It is classified as a Class 2 immunoelectrophoretic immunoglobulin device for clinical 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: K-ASSAY - Kamiya Biomedical Company, Kamiya Biomedical Company - Clinical Diagnostics - IgA ... - K-ASSAY, PDF K ASSAY Immunoturbidimetric Assay Reagents for ... - Kamiya Biomedical, PDF KAMIYA BIOMEDICAL COMPANY K ASSAY IgA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993213 | Class II | Active |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Co.
Sources (1)
- FDA 510(k) K993213 24 fields · synced Oct 6, 2026