Cleared Traditional

K150658 - Optilite FreeLite Kappa Free Kit

K150658 is the FDA 510(k) clearance for Optilite FreeLite Kappa Free Kit by The Binding Site Group , Ltd.. It is a Class 2 Immunology device (product code DFH) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K150658 · The Binding Site Group , Ltd. · Immunology device
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Aug 2015
Decision
166d
Days
Class 2
Risk

K150658 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 Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 26, 2015 after a review of 166 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 Group , Ltd. devices

Submission Details

510(k) Number K150658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2015
Decision Date August 26, 2015
Days to Decision 166 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 104d · This submission: 166d
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 36
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K150658.
N Latex FLC kappa assay, N Latex FLC lambda assay
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Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
K173732 · The Binding Site Group , Ltd. · Aug 2018
Diazyme Human Kappa Free Light Chain Assay
K181438 · Diazyme Laboratories, Inc. · Jun 2018
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
K120056 · The Binding Site Group , Ltd. · Apr 2013
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
K082503 · Siemens Healthcare Diagnostics · Dec 2008
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
K070900 · The Binding Site, Ltd. · Nov 2007