510(k) K160819
K160819 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit". The FDA issued a decision of Substantially Equivalent on June 16, 2016. 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
- June 16, 2016
- Date Received
- March 24, 2016
- 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.