Cleared Traditional

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

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

About This 510(k) Submission

K161854 is an FDA 510(k) clearance for the Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS, a Immunoglobulin G Kappa Heavy And Light Chain Combined (Class II — Special Controls, product code PCN), submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on October 4, 2016, 90 days after receiving the submission on July 6, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K161854 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PCN — Immunoglobulin G Kappa Heavy And Light Chain Combined
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510
Definition Intended For The In-vitro Quantification Of Igg Kappa Concentration In Human Serum.