Immunoglobulin M Kappa Heavy And Light Chain Combined
The Immunoglobulin M Kappa Heavy and Light Chain Combined assay is an immunology in vitro diagnostic device intended for the in vitro quantification of IgM kappa concentration in human serum, with results interpreted in conjunction with previous test results and clinical information. It falls under the Immunology medical specialty and is classified as a Class 2 device under regulation 866.5510, requiring 510(k) premarket notification. These assays are used in the diagnosis and monitoring of IgM-related plasma cell disorders and Waldenstrom's macroglobulinemia. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PDE
- 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 IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | Dec 18, 2015 | Substantially Equivalent | The Binding Site Group , Ltd. |
| K140686 | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS | Aug 06, 2014 | Substantially Equivalent | The Binding Site Group , Ltd. |
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.