K152389 is an FDA 510(k) clearance for the Optilite Hevylite IgM Kappa Kit. This device is classified as a Immunoglobulin M Kappa Heavy And Light Chain Combined (Class II - Special Controls, product code PDE).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on December 18, 2015, 116 days after receiving the submission on August 24, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510. 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) Number | K152389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2015 |
| Decision Date | December 18, 2015 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | PDE — Immunoglobulin M Kappa Heavy And Light Chain Combined |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
| 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. |