CFQ · Radioimmunoassay, Immunoglobulins (G, A, M)
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | CFQ |
|---|---|
| Device Name | Radioimmunoassay, Immunoglobulins (G, A, M) |
| 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K981786 | IGA MININEPH ANTISERUM | The Binding Site, Ltd. | Nov 24, 1999 | SESE |
| K990552 | IMMUNOGLOBULIN A TEST SYSTEM | Dade Behring, Inc. | Mar 25, 1999 | SESE |
| K990551 | IGG FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 25, 1999 | SESE |
| K990553 | IGM FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 22, 1999 | SESE |
| K951055 | OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Apr 17, 1995 | SESE |
| K951013 | OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Apr 17, 1995 | SESE |
| K950900 | OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Mar 27, 1995 | SESE |
| K891188 | TITAN GEL IFE TRIVALENT ANTISERUM | Helena Laboratories | Mar 22, 1989 | SESE |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Atlantic Antibodies | Feb 23, 1989 | SESE |
| K881928 | MONOCLONAL RADIAL IMMUNODIFFUSION KIT | The Binding Site, Ltd. | Jul 8, 1988 | SESE |
| K881827 | IMMUNOGLOBULIN A TEST SYSTEM | The Binding Site, Ltd. | Jun 10, 1988 | SESE |
| K881828 | IMMUNOGLOBULIN M TEST SYSTEM | The Binding Site, Ltd. | Jun 6, 1988 | SESE |
Top Applicants
- The Binding Site, Ltd. — 4 clearances
- Dade Behring, Inc. — 3 clearances
- Olympus America, Inc. — 3 clearances
- Atlantic Antibodies — 1 clearance
- Helena Laboratories — 1 clearance
