KTO · Reagent, Immunoassay, Igg
Immunology · 21 CFR 866.5530 · Class 1
Overview
| Product Code | KTO |
|---|---|
| Device Name | Reagent, Immunoassay, Igg |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K894416 | RAICHEM(TM) SPIA(TM) IGG REAGENTS | Reagents Applications, Inc. | Aug 1, 1989 | SESE |
| K854483 | KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT | Kallestad Laboratories, Inc. | Dec 11, 1985 | SESE |
Top Applicants
- Reagents Applications, Inc. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
