DEH · Lambda, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5550 · Class 2
Overview
| Product Code | DEH |
|---|---|
| Device Name | Lambda, 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 53)
Showing 20 most recent of 53 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172471 | VENTANA CD30 (Ber-H2) RxDx Assay | Ventana Medical Systems, Inc. | May 8, 2018 | SESE |
| K140396 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site Group , Ltd. | Apr 16, 2014 | SESE |
| K083601 | LAMBDA LIGHT CHAINS | SENTINEL CH. SpA | Jun 22, 2009 | SESE |
| K033811 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER | The Binding Site, Ltd. | Jan 30, 2004 | SESE |
| K031016 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II | The Binding Site, Ltd. | Jul 15, 2003 | SESE |
| K023131 | FREELITE HUMAN LAMBDA FREE KIT | The Binding Site, Ltd. | Jan 21, 2003 | SESE |
| K010441 | FREELITE KAPPA FREE KIT | The Binding Site, Ltd. | Apr 26, 2001 | SESE |
| K010440 | FREELITE LAMBDA FREE KIT | The Binding Site, Ltd. | Apr 26, 2001 | SESE |
| K003671 | LAMBDA IMMAGE FREELITE KIT | The Binding Site, Ltd. | Feb 1, 2001 | SESE |
| K002563 | SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | Oct 26, 2000 | SESE |
| K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dako Corp. | Dec 12, 1997 | SESE |
| K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) | Dako Corp. | Nov 6, 1997 | SESE |
| K940583 | VENTANA CD45 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Oct 20, 1997 | SESE |
| K973393 | CHEMMATE LCA | Ventana Medical Systems, Inc. | Sep 25, 1997 | SESE |
| K941514 | VENTANA ANTI-S100 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Apr 25, 1997 | SESE |
| K941170 | VENTANA ANTI-MELANOMA PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Apr 22, 1997 | SESE |
| K941707 | ANTI-MUSCLE ACTIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Apr 21, 1997 | SESE |
| K941784 | VENTANA ANTI-CD8 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Feb 14, 1997 | SESE |
| K941604 | VENTANA ANTI-CD4 PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Feb 14, 1997 | SESE |
| K941516 | VENTANNA ANTI-DESMIN PRIMARY ANTIBODY | Ventana Medical Systems, Inc. | Feb 10, 1997 | SESE |
Top Applicants
- Ventana Medical Systems, Inc. — 17 clearances
- Dako Corp. — 9 clearances
- The Binding Site, Ltd. — 7 clearances
- Biotek Solutions, Inc. — 4 clearances
- Kallestad Laboratories, Inc. — 4 clearances
