K140686 is an FDA 510(k) clearance for the HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS. 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 August 6, 2014, 140 days after receiving the submission on March 19, 2014.
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 | K140686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2014 |
| Decision Date | August 06, 2014 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| 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. |