DAS · Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Immunology · 21 CFR 866.5530 · Class 1
Overview
| Product Code | DAS |
|---|---|
| Device Name | Igg (Fc Fragment Specific), Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5530 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K982023 | PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT | Inova Diagnostics, Inc. | Sep 4, 1998 | SESE |
| K944876 | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT | Research Diagnostics, Inc. | Dec 15, 1994 | SESE |
| K943205 | HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) | Research Diagnostics, Inc. | Sep 7, 1994 | SESE |
| K943098 | HUMAN IGG SUBCLASSES ELISA COMBI KIT | Research Diagnostics, Inc. | Sep 7, 1994 | SESE |
| K895600 | HUMAN (IGG) SUBCLASS (EIA) KIT | The Binding Site, Ltd. | Nov 8, 1989 | SESE |
| K790708 | ANTISERUM TO HUMAN IG G FC FRAGMENTS | Kent Laboratories, Inc. | Aug 22, 1979 | SESE |
| K790715 | ANTISERUM TO HUMAN FC | Kent Laboratories, Inc. | Aug 16, 1979 | SESE |
| K761156 | AMINOGLYCOSIDE CONTROLS | Supelco, Inc. | Dec 9, 1976 | SESE |
Top Applicants
- Research Diagnostics, Inc. — 3 clearances
- Kent Laboratories, Inc. — 2 clearances
- Inova Diagnostics, Inc. — 1 clearance
- Supelco, Inc. — 1 clearance
- The Binding Site, Ltd. — 1 clearance
