Cleared Traditional

K161854 - Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS

K161854 is an FDA 510(k) clearance for Hevylite Human IgG Kappa Kit for use on..., manufactured by The Binding Site Group , Ltd.. The device is a Class 2 Immunology device with product code PCN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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.

View all The Binding Site Group , Ltd. devices

FDA 510(k) Submission Details - K161854

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 105d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PCN Device Classification - Class 2, Special Controls

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.