Home / 510(k) Clearances / K151759

510(k) K151759

Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS by The Binding Site Group , Ltd. — Product Code OPX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2015
Date Received
June 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoglobulin A Kappa Heavy & Light Chain Combined
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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.

Other clearances by The Binding Site Group , Ltd.

  • K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (October 17, 2025)
  • K250549 — Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (May 23, 2025)
  • K192116 — Human IgA liquid reagent kit for Use on SPAPlus (September 4, 2019)
  • K191985 — Optilite IgA Kit (August 19, 2019)
  • K191635 — Optilite IgM Kit (July 15, 2019)
  • K191465 — Human IgM Kit for use on SPAPlus (June 27, 2019)
  • K190686 — Optilite IgM CSF Kit (May 28, 2019)
  • K183151 — Optilite IgA CSF Kit (January 23, 2019)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K173732 — Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit (August 23, 2018)

Other clearances for product code OPX

  • K160819 — Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit (June 16, 2016)
  • K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA (March 18, 2014)