K151759 is an FDA 510(k) clearance for the Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS. This device is classified as a Immunoglobulin A Kappa Heavy & Light Chain Combined (Class II - Special Controls, product code OPX).
Submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on November 6, 2015, 130 days after receiving the submission on June 29, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510. 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) Number | K151759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2015 |
| Decision Date | November 06, 2015 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | OPX — Immunoglobulin A Kappa Heavy & Light Chain Combined |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
| 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. |