Cleared Traditional

K250159 - Immunoglobulin Isotypes (GAM) for the EXENT Analyser (FDA 510(k) Clearance)

Also includes:
EXENT Analyser

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K250159 is an FDA 510(k) clearance for the Immunoglobulin Isotypes (GAM) for the EXENT Analyser. Classified as Mass Spectrometric, Immunoglobulins (g, A, M, D, E) (product code SGG), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on October 17, 2025 after a review of 269 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Binding Site Group , Ltd. devices

Submission Details

510(k) Number K250159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 104d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SGG Mass Spectrometric, Immunoglobulins (g, A, M, D, E)
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.