Cleared Special

K191465 - Human IgM Kit for use on SPAPlus (FDA 510(k) Clearance)

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191465 · The Binding Site Group , Ltd. · Immunology device
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Jun 2019
Decision
24d
Days
Class 2
Risk

K191465 is an FDA 510(k) clearance for the Human IgM Kit for use on SPAPlus. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on June 27, 2019 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all The Binding Site Group , Ltd. devices

Submission Details

510(k) Number K191465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2019
Decision Date June 27, 2019
Days to Decision 24 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 104d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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.