Cleared Traditional

HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS

K140686 · The Binding Site Group , Ltd. · Immunology

Aug 2014

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K140686 is an FDA 510(k) clearance for the HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS, a Immunoglobulin M Kappa Heavy And Light Chain Combined (Class II — Special Controls, product code PDE), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 6, 2014, 140 days after receiving the submission on March 19, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K140686 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2014
Decision Date	August 06, 2014
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	PDE — Immunoglobulin M 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 Igm Kappa Concentration In Human Serum. The Result Is To Be Used With Previously Diagnosed Igm Waldenstoms Macrolobulinaemia, In Conjunction With Other Clinical And Laboratory Findings.