# K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Oct 17, 2025 after 269 days
- Product code: SGG (Mass Spectrometric, Immunoglobulins (G, A, M, D, E))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955907 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072889: Human Igg Subclass Liquid Reagent Kits for Use on the Spaplus Analyser, The Binding Site, Ltd. (2008) Summary page 6.
- K191985: Optilite IgA Kit, The Binding Site Group, Ltd. (2019) Summary page 6.
- K191635: Optilite IgM Kit, The Binding Site Group, Ltd. (2019) Summary page 6.
- K960669: Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF Kits, Morax (1996) Summary page 6.

## Recalls of this device
- Apr 16, 2026 · Class II · Z-2362-2026: It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. The potential clinical hazards include 

## Indications for use
Immunoglobulin Isotypes (GAM) for the EXENT Analyser: The Immunoglobulin Isotypes (GAM) for the EXENT Analyser is a MALDI-TOF mass spectrometry immunoassay that is used in conjunction with the Binding Site Optilite IgG, IgA and IgM assays for the semi-quantitative in vitro measurement of monoclonal IgG, IgA, and IgM as a reflex test in serum for patients with a result suggestive of the presence of monoclonal immunoglobulins by serum protein electrophoresis (gel or capillary zone electrophoresis), or with an abnormal serum free light chain concentration and free light chain ratio result. The assay is intended for use as an aid in the evaluation of monoclonal gammopathy of undetermined significance (MGUS); and as an aid in the diagnosis of smouldering multiple myeloma (SMM), multiple myeloma (MM), Waldenström's macroglobulinaemia, and AL amyloidosis. Assay results should be used in conjunction with other laboratory and clinical findings. EXENT Analyser: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. The device is designed for professional in vitro diagnostic use only and it is not a device for self-testing.

Source page: https://510kreport.com/device/K250159
Methodology: https://510kreport.com/methodology