Cleared Traditional

K161854 - Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS (FDA 510(k) Clearance)

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

K161854 · The Binding Site Group , Ltd. · Immunology device
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Oct 2016
Decision
90d
Days
Class 2
Risk

K161854 is an FDA 510(k) clearance for the Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambd.... Classified as Immunoglobulin G Kappa Heavy And Light Chain Combined (product code PCN), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on October 4, 2016 after a review of 90 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 K161854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2016
Decision Date October 04, 2016
Days to Decision 90 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
14d faster than avg
Panel avg: 104d · This submission: 90d
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.