PDE — Immunoglobulin M Kappa Heavy And Light Chain Combined Class II

FDA Device Classification

Classification Details

Product Code: PDE
Device Class: Class II
Regulation Number: 866.5510
Submission Type
Review Panel: IM
Medical Specialty: Immunology
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K152389	binding site group	Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit	December 18, 2015
K140686	binding site group	HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS	August 6, 2014