Cleared Special

K191635 - Optilite IgM Kit (FDA 510(k) Clearance)

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

K191635 · The Binding Site Group , Ltd. · Immunology device
Download Printable Device Report (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.

View all The Binding Site Group , Ltd. devices

Submission Details

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
78d faster than avg
Panel avg: 104d · This submission: 26d
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.

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.
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · Siemens Healthcare Diagnostics Products GmbH · Dec 2023
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