Product code OPX

Device name: Immunoglobulin A Kappa Heavy & Light Chain Combined
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5510
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K160819	Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit	The Binding Site Group , Ltd.	2016-06-16
K151759	Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS	The Binding Site Group , Ltd.	2015-11-06
K140105	HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII	The Binding Site	2014-03-18

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05051700016919	Hevylite® Human IgA Kappa Kit for use on the Siemens BN™II	THE BINDING SITE GROUP LIMITED	2016-09-24
05051700017985	Hevylite® Human IgA Kappa Kit for use on the SPAPLUS	THE BINDING SITE GROUP LIMITED	2016-09-24
05051700018487	Optilite Hevylite® IgA Kappa Kit	THE BINDING SITE GROUP LIMITED	2016-09-24

Related 510(k) Records#