Cleared Traditional

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

K160819 · The Binding Site Group , Ltd. · Immunology
Jun 2016
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K160819 is an FDA 510(k) clearance for the Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit, a Immunoglobulin A Kappa Heavy & Light Chain Combined (Class II — Special Controls, product code OPX), submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on June 16, 2016, 84 days after receiving the submission on March 24, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K160819 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2016
Decision Date June 16, 2016
Days to Decision 84 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code OPX — Immunoglobulin A Kappa Heavy & Light Chain Combined
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510
Definition Intended For The In-vitro Quantification Of Iga Kappa Concentration In Human Serum. The Result Is To Be Used With Previously Diagnosed Iga Multiple Myeloma, In Conjunction With Other Clinical And Laboratory Findings. For Previously Diagnosed Iga Multiple Myeloma Patients.