Cleared Traditional

Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit

K152389 · The Binding Site Group , Ltd. · Immunology
Dec 2015
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K152389 is an FDA 510(k) clearance for the Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit, 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 December 18, 2015, 116 days after receiving the submission on August 24, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K152389 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2015
Decision Date December 18, 2015
Days to Decision 116 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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.