Cleared Special

K191635 - Optilite IgM Kit

K191635 is an FDA 510(k) clearance for Optilite IgM Kit, manufactured by The Binding Site Group , Ltd.. The device is a Class 2 Immunology device with product code CFN cleared through the Special 510(k) pathway after a 26-day FDA review.

K191635 · The Binding Site Group , Ltd. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
26d
Days
Class 2
Risk

K191635 is an FDA 510(k) clearance for the Optilite IgM Kit. 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 July 15, 2019 after a review of 26 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.

FDA 510(k) Submission Details - K191635

510(k) Number K191635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2019
Decision Date July 15, 2019
Days to Decision 26 days
Submission Type Special
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
79d faster than avg
Panel avg: 105d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

CFN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 60
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K191635.
Immunoglobulin G (IgG)
K221114 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Aug 2023
Human IgA liquid reagent kit for Use on SPAPlus
K192116 · The Binding Site Group , Ltd. · Sep 2019
Optilite IgA Kit
K191985 · The Binding Site Group , Ltd. · Aug 2019
Human IgM Kit for use on SPAPlus
K191465 · The Binding Site Group , Ltd. · Jun 2019
Optilite IgM CSF Kit
K190686 · The Binding Site Group , Ltd. · May 2019
Optilite IgA CSF Kit
K183151 · The Binding Site Group , Ltd. · Jan 2019
K191635 · Optilite IgM Kit
Download PDF FDA Summary The Binding Site Grou…