Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
FDA 510(k) K250159 · The Binding Site Group , Ltd.
510(k) numberK250159
Submission
- Device name
- Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
- Applicant
- The Binding Site Group , Ltd.
Birmingham, GB - Received
- January 21, 2025
- Decision date
- October 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SGG – Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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.
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Questions and answers
When was Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser cleared by the FDA?
Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (K250159) received a 510(k) decision of Substantially Equivalent on October 17, 2025, 269 days after the submission was received.
What is the product code of K250159?
The FDA product code is SGG – Mass Spectrometric, Immunoglobulins (G, A, M, D, E), a Class II (moderate risk) device regulated under 21 CFR 866.5510.