OPX — Immunoglobulin A Kappa Heavy & Light Chain Combined Class II
Classification Details
- Product Code
- OPX
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K160819 | binding site group | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | June 16, 2016 |
| K151759 | binding site group | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit f | November 6, 2015 |
| K140105 | binding site | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA | March 18, 2014 |