IGA Subclass RID Kit for Diagnostic Use
by The Binding Site, Ltd. 510(k)
Active
510(k) K931806
Overview
This device is an Immunoglobulin A (IgA) subclass radioimmunodiffusion (RID) test kit, designed for the quantitative measurement of IgA subclasses in serum or plasma. It employs a radial immunodiffusion technique to detect and differentiate IgA1 and IgA2 subclasses, aiding in the diagnosis and monitoring of immunologic disorders, including primary immunodeficiencies and other conditions affecting immunoglobulin profiles.
The IGA Subclass RID Kit is supplied as a single-use diagnostic reagent kit, intended for use in clinical laboratories. It includes antigen, antiserum, controls, and other necessary components for performing the assay. The kit is not sterile and must be handled in accordance with standard laboratory practices. It is classified under FDA product code CZP and has received a Traditional 510(k) clearance from the FDA, with a decision date of July 16, 1993. Storage and handling should follow manufacturer guidelines to ensure accuracy and reliability of results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931806 | Date16 Jul 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CZP
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from The Binding Site, Ltd.
Questions
What is the IgA Subclass RID Kit used for?
The IgA Subclass RID Kit is designed for the quantitative measurement of Immunoglobulin A (IgA) subclasses—specifically IgA1 and IgA2—in serum or plasma samples. It employs radial immunodiffusion (RID) to differentiate these subclasses, aiding in the diagnosis and monitoring of immunologic disorders, including primary immunodeficiencies and other conditions affecting immunoglobulin profiles.
How is the IgA Subclass RID Kit supplied, and is it sterile?
The kit is supplied as a single-use diagnostic reagent kit containing antigen, antiserum, controls, and other necessary components for performing the assay. It is not sterile, so it must be handled in compliance with standard laboratory practices to prevent contamination.
Is this kit intended for reuse, or is it single-use?
The IgA Subclass RID Kit is explicitly designed for single-use only. Each kit is meant for one assay, and reuse is not recommended or supported by the manufacturer to ensure accurate and reliable results.
What regulatory approval does this kit hold?
The kit has received Traditional 510(k) clearance from the FDA under product code CZP, with a decision date of July 16, 1993. It is classified under the Immunology specialty and was reviewed by the Immunology (IM) Advisory Committee.
How should the IgA Subclass RID Kit be stored?
Storage and handling should follow the manufacturer’s guidelines to maintain the kit’s integrity and accuracy. While specific storage conditions (e.g., temperature, humidity) are not detailed here, proper laboratory practices—such as protecting from light, moisture, and extreme temperatures—are critical to preserving the components for reliable assay performance.