Product code OPX
- Device name
- Immunoglobulin A Kappa Heavy & Light Chain Combined
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5510
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Intended for the in-vitro quantification of iga kappa concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | The Binding Site Group , Ltd. | 2016-06-16 |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2015-11-06 |
| K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | The Binding Site | 2014-03-18 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 05051700017985 | Hevylite® Human IgA Kappa Kit for use on the SPAPL | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700018487 | Optilite Hevylite® IgA Kappa Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |