DFT · Igm, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5550 · Class 2
Overview
| Product Code | DFT |
|---|---|
| Device Name | Igm, 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 (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K983132 | IGM | Abbott Laboratories | Nov 4, 1998 | SESE |
| K962201 | QUANTEX IGM | Instrumentation Laboratory CO | Sep 25, 1996 | SESE |
| K955797 | IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | Apr 5, 1996 | SESE |
| K945522 | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS | Beckman-Diagnostic Systems Group | Dec 12, 1994 | SESE |
| K901453 | QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD | Isolab, Inc. | Apr 12, 1990 | SESE |
| K894417 | RAICHEM(TM) SPIA(TM) IGM REAGENTS | Reagents Applications, Inc. | Aug 2, 1989 | SESE |
| K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | Orion Diagnostica, Inc. | Oct 27, 1988 | SESE |
| K880828 | WAKO(TM) IGM-HA DIRECT | Wako Chemicals USA, Inc. | Mar 25, 1988 | SESE |
| K873871 | IMMUNOGLOBULINS M | Unipath , Ltd. | Oct 13, 1987 | SESE |
| K872237 | KALLESTAD QM300 IGM ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Jul 9, 1987 | SESE |
| K871498 | TITAN GEL IMMUNOFIX CONTROLS | Helena Laboratories | Apr 29, 1987 | SESE |
| K862762 | TINA-QUANT(R) IGM | Boehringer Mannheim Corp. | Sep 8, 1986 | SESE |
| K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | Kallestad Laboratories, Inc. | Feb 28, 1986 | SESE |
| K853469 | GILFORD IMMUNOGLOBULIN M REAGENT | Gilford | Sep 16, 1985 | SESE |
| K842327 | AMER. HISTO-ID SYS PRIMARY IGM S7920-31 | Bartels Immunodiagnostic Supplies, Inc. | Aug 2, 1984 | SESE |
| K841814 | OPTIMATE IGM TEST | Miles Laboratories, Inc. | Jun 22, 1984 | SESE |
| K832265 | FITC GOAT ANTI-HUMAN IGM H CHAIN | Gelco Diagnostics, Inc. | Oct 31, 1983 | SESE |
| K832259 | GOAT ANTI-HUMAN IGM H CHAIN | Gelco Diagnostics, Inc. | Oct 28, 1983 | SESE |
| K831608 | FIAX IGM TEST KIT | Intl. Diagnostic Technology | Jun 22, 1983 | SESE |
| K831103 | TIA-IGM REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | Apr 27, 1983 | SESE |
Top Applicants
- Kallestad Laboratories, Inc. — 3 clearances
- Gelco Diagnostics, Inc. — 2 clearances
- Icl Scientific — 2 clearances
- Isolab, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
