Immunoglobulin Control
by Syva Co. 510(k)
Active
510(k) K823566
Overview
The Immunoglobulin Control is an in-vitro diagnostic device used in immunology to measure immunoglobulin A (IgA) concentrations in serum using antigen-antiserum immunochemical methods, with associated control materials for assay verification. It is classified as Iga, Antigen, Antiserum, Control under product code CZP.
Supplied by Syva Co., this device received FDA 510(k) clearance (K823566) on December 30, 1982, and is classified as a Class II device with special controls. It is intended for use in laboratory settings for the verification of assay performance in IgA testing.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823566 | Date30 Dec 1982 | 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- Withdrawn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 Syva Co.
Questions
What is the Immunoglobulin Control used for?
The Immunoglobulin Control is used in immunology to verify the performance of assays measuring immunoglobulin A (IgA) concentrations in serum, ensuring accuracy through antigen-antiserum immunochemical methods with associated control materials.
How is the Immunoglobulin Control supplied and intended for use?
Supplied by Syva Co., the device is intended for use in laboratory settings as an in-vitro diagnostic control material to verify assay performance in IgA testing, supporting consistent and reliable immunology testing workflows.
Is the Immunoglobulin Control a single-use or reusable device?
The Immunoglobulin Control is intended for single-use in assay verification procedures, as it is a control material designed to be consumed during use to ensure the accuracy and reproducibility of IgA measurements in each test run.