Cleared Traditional

K152389 - Optilite Hevylite IgM Kappa Kit (FDA 510(k) Clearance)

Also includes:
Optilite Hevylite IgM Lambda Kit

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

K152389 · The Binding Site Group , Ltd. · Immunology device
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Dec 2015
Decision
116d
Days
Class 2
Risk

K152389 is an FDA 510(k) clearance for the Optilite Hevylite IgM Kappa Kit. Classified as Immunoglobulin M Kappa Heavy And Light Chain Combined (product code PDE), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on December 18, 2015 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 K152389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2015
Decision Date December 18, 2015
Days to Decision 116 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 104d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDE Immunoglobulin M Kappa Heavy And Light Chain Combined
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
Definition Intended For The In-vitro Quantification Of Igm Kappa Concentration In Human Serum. The Result Is To Be Used With Previously Diagnosed Igm Waldenstoms Macrolobulinaemia, In Conjunction With Other Clinical And Laboratory Findings.
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.