JKM · Immunochemical, Bence-Jones Protein
Immunology · 21 CFR 866.5150 · Class 2
Overview
| Product Code | JKM |
|---|---|
| Device Name | Immunochemical, Bence-Jones Protein |
| Regulation | 21 CFR 866.5150 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K080916 | CAPILLARYS URINE | Sebia | Jul 1, 2008 | SESE |
| K070486 | CAPILLARYS URINE (PN 2012) | Sebia, Inc. | Dec 21, 2007 | SESE |
| K050119 | PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT | Beckman Coulter, Inc. | May 6, 2005 | SESE |
| K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT | Morax | Mar 4, 1998 | SESE |
Top Applicants
- Sebia, Inc. — 1 clearance
- Sebia — 1 clearance
- Morax — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
