K250159 is an FDA 510(k) clearance for the Immunoglobulin Isotypes (GAM) for the EXENT Analyser. This device is classified as a Mass Spectrometric, Immunoglobulins (g, A, M, D, E) (Class II - Special Controls, product code SGG).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on October 17, 2025, 269 days after receiving the submission on January 21, 2025.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510. The Test System Is Intended For The (semi-)quantitative Or Quantitative Determination Of Monoclonal Immunoglobulins (m-proteins) And/or The Identification Of Immunoglobulin Isotype Of M-proteins In Human Specimens By Mass Spectrometric Methods..
| 510(k) Number | K250159 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2025 |
| Decision Date | October 17, 2025 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | SGG — Mass Spectrometric, Immunoglobulins (g, A, M, D, E) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
| Definition | The Test System Is Intended For The (semi-)quantitative Or Quantitative Determination Of Monoclonal Immunoglobulins (m-proteins) And/or The Identification Of Immunoglobulin Isotype Of M-proteins In Human Specimens By Mass Spectrometric Methods. |