DeviceClearance

Product code PDE— Immunology

HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS

Classification name
Immunoglobulin M Kappa Heavy And Light Chain Combined
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PDE under 21 CFR 866.5510, via openFDA

Market context for product code PDE

FDA has cleared 2 devices under product code PDE between 2014 and 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PDE

Recent clearances under product code PDE

Data sourced from openFDA. This site is unofficial and independent of the FDA.