510(k) K151759
K151759 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS". The FDA issued a decision of Substantially Equivalent on November 6, 2015. The device falls under product code OPX (Immunoglobulin A Kappa Heavy & Light Chain Combined), a Class II device regulated under 21 CFR 866.5510. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2015
- Date Received
- June 29, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoglobulin A Kappa Heavy & Light Chain Combined
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type
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.