510(k) K250159
K250159 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser". The FDA issued a decision of Substantially Equivalent on October 17, 2025. The device falls under product code SGG (Mass Spectrometric, Immunoglobulins (G, A, M, D, E)), a Class II device regulated under 21 CFR 866.5510. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2025
- Date Received
- January 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type
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.