DBY · Fab, Rhodamine, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5520 · Class 1
Overview
| Product Code | DBY |
|---|---|
| Device Name | Fab, Rhodamine, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5520 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).
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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022067 | CONVOY ADVANCED DELIVERY SHEATH | Boston Scientific | Sep 11, 2002 | SESE |
| K013919 | TORFLEX TRANSSEPTAL GUIDING SHEATH | Baylis Medical Co., Inc. | Feb 22, 2002 | SESE |
| K013304 | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER | Becton Dickinson Infusion Therapy Systems, Inc. | Jan 2, 2002 | SESE |
| K013866 | CONVOY ADVANCED DELIVERY SHEATH KIT | Boston Scientific | Dec 14, 2001 | SESE |
| K013282 | GORE INTRODUCER SHEATH | W. L. Gore & Associates, Inc. | Dec 14, 2001 | SESE |
| K771144 | RHODAMINE-CONJUGATED ANTISERUM | Kent Laboratories, Inc. | Jul 14, 1977 | SESE |
Top Applicants
- Boston Scientific — 2 clearances
- W. L. Gore & Associates, Inc. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance
- Becton Dickinson Infusion Therapy Systems, Inc. — 1 clearance
- Baylis Medical Co., Inc. — 1 clearance
