Cleared Traditional

K132555 - HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (FDA 510(k) Clearance)

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

K132555 · The Binding Site · Immunology device
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Dec 2013
Decision
128d
Days
Class 2
Risk

K132555 is an FDA 510(k) clearance for the HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT. Classified as Immunoglobulin G Kappa Heavy And Light Chain Combined (product code PCN), Class II - Special Controls.

Submitted by The Binding Site (Birmingham, GB). The FDA issued a Cleared decision on December 20, 2013 after a review of 128 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.

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Submission Details

510(k) Number K132555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2013
Decision Date December 20, 2013
Days to Decision 128 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
24d slower than avg
Panel avg: 104d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCN Immunoglobulin G 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 Igg Kappa Concentration In Human Serum.
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.