Cleared Traditional

HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII

K140105 · The Binding Site · Immunology
Mar 2014
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K140105 is an FDA 510(k) clearance for the HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII, a Immunoglobulin A Kappa Heavy & Light Chain Combined (Class II — Special Controls, product code OPX), submitted by The Binding Site (Birmingham, GB). The FDA issued a Cleared decision on March 18, 2014, 62 days after receiving the submission on January 15, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K140105 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2014
Decision Date March 18, 2014
Days to Decision 62 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.