Immunoglobulin A Kappa Heavy & Light Chain Combined
The Immunoglobulin A Kappa Heavy & Light Chain Combined is an in vitro diagnostic reagent used for the quantitative measurement of IgA kappa immunoglobulin concentration in human serum. It is intended for use in patients with previously diagnosed IgA multiple myeloma, used in conjunction with other clinical and laboratory findings to monitor the disease. This device falls under FDA Class 2, meaning it requires a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. The product code is OPX under regulation 866.5510, within the Immunology medical specialty. It is eligible for third-party 510(k) review and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OPX
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | Jun 16, 2016 | Substantially Equivalent | The Binding Site Group , Ltd. |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | Nov 06, 2015 | Substantially Equivalent | The Binding Site Group , Ltd. |
| K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | Mar 18, 2014 | Substantially Equivalent | The Binding Site |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.