DAO · Igm (Mu Chain Specific), Antigen, Antiserum, Control
Immunology · 21 CFR 866.5550 · Class 2
Overview
| Product Code | DAO |
|---|---|
| Device Name | Igm (Mu Chain Specific), Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5550 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040431 | ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 | Roche Diagnostics Corp. | Mar 10, 2004 | SESE |
| K982639 | SPIFE URINE IFE | Helena Laboratories | Nov 4, 1998 | SESE |
| K955908 | BOEHRINGER MANNHEIM IGM ASSAY | Boehringer Mannheim Corp. | Feb 9, 1996 | SESE |
| K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | Applications Lab | Mar 14, 1985 | SESE |
| K841992 | MODIFICATION TO ACS CORONARY GUIDING | Advanced Cardiovascular Systems, Inc. | Jun 11, 1984 | SESE |
| K812487 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM | Dako Corp. | Sep 23, 1981 | SESE |
| K800450 | GEMENI IGM ASSAY | Electro-Nucleonics Laboratories, Inc. | Apr 24, 1980 | SESE |
| K790705 | ANTISERUM TO HUMAN IGM | Kent Laboratories, Inc. | Apr 12, 1979 | SESP |
Top Applicants
- Advanced Cardiovascular Systems, Inc. — 1 clearance
- Applications Lab — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Dako Corp. — 1 clearance
- Electro-Nucleonics Laboratories, Inc. — 1 clearance
