PCN · Immunoglobulin G Kappa Heavy And Light Chain Combined
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | PCN |
|---|---|
| Device Name | Immunoglobulin G Kappa Heavy And Light Chain Combined |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | The Binding Site Group , Ltd. | Feb 15, 2018 | SESE |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | The Binding Site Group , Ltd. | Oct 4, 2016 | SESE |
| K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | The Binding Site | Dec 20, 2013 | SESE |
Top Applicants
- The Binding Site Group , Ltd. — 2 clearances
- The Binding Site — 1 clearance
