K160819 is an FDA 510(k) clearance for the Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit. 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 June 16, 2016, 84 days after receiving the submission on March 24, 2016.
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 | K160819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2016 |
| Decision Date | June 16, 2016 |
| Days to Decision | 84 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. |