21 CFR 866.5530 — Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5530
Identification
An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DAS | Igg (Fc Fragment Specific), Antigen, Antiserum, Control | 1 | 8 | |
| DBH | Fc, Rhodamine, Antigen, Antiserum, Control | 1 | 0 | |
| DBK | Fc, Fitc, Antigen, Antiserum, Control | 1 | 0 | |
| DBN | Fc, Antigen, Antiserum, Control | 1 | 1 | |
| KTO | Reagent, Immunoassay, Igg | 1 | 2 |
