Immunoglobulin Assays-Igg, Iga, Igm
by Syva Co. 510(k)
Active
510(k) K823567
Overview
This device is an immunoglobulin assay system for quantifying Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM) in serum or plasma samples. It employs antigen, antiserum, and control reagents to detect and measure these key immune proteins, aiding in the diagnosis and monitoring of immunodeficiencies, infections, and autoimmune conditions within the field of immunology.
The system is supplied as a reagent kit and is intended for use in clinical laboratories. It is classified under product code CZP and regulated under FDA regulation 866.5510, with a Traditional 510(k) clearance (K823567) granted in 1982. No third-party review was involved, and the device is intended for single-use per the manufacturer’s specifications. Storage and handling conditions are not specified in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823567 | 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- Withdrawn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 clinical conditions can this immunoglobulin assay help diagnose or monitor?
This assay system quantifies Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM) in serum or plasma, aiding in the diagnosis and monitoring of immunodeficiencies, infections, and autoimmune conditions. By measuring these key immune proteins, clinicians can assess immune function and track disease progression or treatment response in patients.
Is this device intended for use in outpatient settings, or is it strictly for clinical laboratories?
The device is explicitly intended for use in clinical laboratories only, as stated in the regulatory data. It is supplied as a reagent kit and is not designed for point-of-care or outpatient testing.
How is this assay system supplied, and is it meant for single-use or reusable applications?
The immunoglobulin assay system is supplied as a reagent kit containing antigen, antiserum, and control reagents. According to the manufacturer’s specifications referenced in the regulatory data, it is intended for single-use only per test run.
What regulatory pathway was followed for this device’s clearance, and when was it granted?
This device received a Traditional 510(k) clearance (K823567) under FDA regulation 866.5510, classified under product code CZP. The submission was filed on December 3, 1982, and granted on December 30, 1982, with no third-party review involved. The decision was based on substantial equivalence to a predicate device.