The Binding Site Group , Ltd. · Class II · Cleared Oct 17, 2025
| K-number | K250159 |
| Device name | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser |
| Applicant | The Binding Site Group , Ltd. |
| Product code | SGG |
| Device class | Class II |
| Decision date | Oct 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.5510 |
The Immunoglobulin Isotypes (GAM) for the EXENT Analyser is a MALDI-TOF mass spectrometry immunoassay used with Optilite IgG, IgA, and IgM assays to semi-quantitatively measure monoclonal IgG, IgA, and IgM in serum as a reflex test. It aids in evaluating monoclonal gammopathy of undetermined significance (MGUS) and diagnosing smouldering multiple myeloma, multiple myeloma, Waldenström's macroglobulinaemia, and AL amyloidosis. The EXENT Analyser is an automated analyzer that combines immunoassay with MALDI-ToF mass spectrometry readout for in vitro diagnostic use only.
The proposed device uses mass spectrometry for detection and reports semi-quantitative monoclonal M-protein concentrations with m/z values and isotype identification, whereas predicate devices (SPAPLUS, Optilite) use turbidimetry and report quantitative total immunoglobulin concentrations. The EXENT uses magnetic bead immunoprecipitation with automatic sample preparation and includes a protein mass calibration standard, while predicates use polyclonal antibody reagents without mass calibration. Both measure the same analytes (IgG, IgA, IgM) in serum with professional prescription-use only application and 2 levels of serum controls.
Precision evaluated per CLSI EP05-A3:2014; linearity per CLSI EP06 ED2:2020; analytical sensitivity per CLSI C62A:2014 and EP17-A2:2012; interference per CLSI EP07 ED3:2018, EP37 ED1:2018, C62-A:2014, and EP12 ED3:2023.
View the full FDA submission: accessdata.fda.gov