Cleared Traditional

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

K250159 · The Binding Site Group , Ltd. · Immunology
Oct 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K250159 is an FDA 510(k) clearance for the Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser, 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 review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K250159 FDA.gov
FDA Decision Cleared 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

Device Classification

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.