DeviceClearance

Product code OPX— Immunology

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

Classification name
Immunoglobulin A Kappa Heavy & Light Chain Combined
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification 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.”

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

Market context for product code OPX

FDA has cleared 3 devices under product code OPX between 2014 and 2016, filed by 2 applicant companies. 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 OPX

Recent clearances under product code OPX

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