Cleared Traditional

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit

K172613 · The Binding Site Group , Ltd. · Immunology
Feb 2018
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K172613 is an FDA 510(k) clearance for the Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit, a Immunoglobulin G Kappa Heavy And Light Chain Combined (Class II — Special Controls, product code PCN), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on February 15, 2018, 168 days after receiving the submission on August 31, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K172613 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2017
Decision Date February 15, 2018
Days to Decision 168 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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.