Cleared Traditional

Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS

K151759 · The Binding Site Group , Ltd. · Immunology
Nov 2015
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K151759 is an FDA 510(k) clearance for the Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS, 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 November 6, 2015, 130 days after receiving the submission on June 29, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K151759 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2015
Decision Date November 06, 2015
Days to Decision 130 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.