Cleared Traditional

K231290 - Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (FDA 510(k) Clearance)

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

K231290 · The Binding Site, Ltd. · Immunology device
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Jan 2024
Decision
265d
Days
Class 2
Risk

K231290 is an FDA 510(k) clearance for the Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Birmingham, GB). The FDA issued a Cleared decision on January 24, 2024 after a review of 265 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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, Ltd. devices

Submission Details

510(k) Number K231290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2023
Decision Date January 24, 2024
Days to Decision 265 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
161d slower than avg
Panel avg: 104d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFH Kappa, Antigen, Antiserum, Control

All 62
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K231290.
Diazyme Human Kappa (k) Free Light Chain Assay
K253358 · Diazyme Laboratories, Inc. · Dec 2025
Optilite® Freelite Mx Kappa Free Kit
K250549 · The Binding Site Group , Ltd. · May 2025
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · Sebia · Feb 2024
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · Sebia · Nov 2022