510(k) · Cleared
Recalled · Class II · 2026Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · SGG Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
Cleared on Oct 17, 2025 as substantially equivalent to K072889 (The Binding Site, Ltd., 2008) and 3 other predicates after a 269-day review. Its family tree reaches back 4 generations to 1996. It has been recalled once.
- Decided
- Oct 17, 2025
- Review
- 269 days
- Class
- Class II
- Product code
- SGG
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K955907 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK955907 Boehringer Mannheim Iga AssayBoehringer Mannheim Corp. · 1996
- 3 generations backK040435 Roche Diagnostics Tina-Quant Iga Gen.2Roche Diagnostics Corp. · 2004 · Recalled
- 2 generations backK103824 Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 2012
- 1 generation backK191985 Optilite IgA KitThe Binding Site Group, Ltd. · 2019
- This deviceK250159 Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955907 | Boehringer Mannheim Iga Assay | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K040435 | Roche Diagnostics Tina-Quant Iga Gen.2 | Roche Diagnostics Corp. | 2004 | 1 |
| −2 | K103824 | Human Iga Liquid Reagent Kit for Use on Spa Plus | The Binding Site | 2012 | — |
| −1 | K191985 | Optilite IgA Kit | The Binding Site Group, Ltd. | 2019 | — |
| 0 (this device) | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SGG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072889 | Human Igg Subclass Liquid Reagent Kits for Use on the Spaplus AnalyserSummary page 6…obulins IgG, IgA, IgM Proprietary Name 510(k) Regulation section Product Code Classification Panel review Human IgG Subclass K072889 21 CFR 866.5510, CFN, Class II IM - Liquid Reagent Kits for Immunogl… | 2008 |
| * | K191985 | Optilite IgA KitSummary page 6…D, and E Nephelometric, (82) Analyser immunological test Immunoglobuli Optilite IgA Kit K191985 system ns (G, A, M) Optilite IgM Kit K191635 Kappa (κ) and Lambda (λ) isotyping of Monoclonal… | 2019 |
| * | K191635 | Optilite IgM KitSummary page 6…immunological test Immunoglobuli Optilite IgA Kit K191985 system ns (G, A, M) Optilite IgM Kit K191635 Kappa (κ) and Lambda (λ) isotyping of Monoclonal immunoglobulins IgG, IgA, IgM Proprietary Name 510(k) Regulat… | 2019 |
| * | K960669 | Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF KitsSummary page 6…obulins IgG, IgA, IgM Proprietary Name 510(k) Regulation section Product Code Classification Panel review *HYDRAGEL K960669 21 CFR 866.5510, CFF, Class II IM - Immunofixation Immunogl… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2026 | Class II | Z-2362-2026 | Under Investigation by firm | 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 false or missed detection of M-protein… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
How does its category compare?
All SGG devicesSGG Mass Spectrometric, Immunoglobulins (G, A, M, D, E): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGG
Too few SGG 510(k)s in any year since 2007 to give a median.
Recalls per year · SGG
No recall names SGG since 2007.
Adverse event reports per year · SGG
No MAUDE report names SGG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (192 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250159 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250159
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026