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510(k) K160819

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit by The Binding Site Group , Ltd. — Product Code OPX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2016
Date Received
March 24, 2016
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.

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Other clearances for product code OPX

  • K151759 — Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit f (November 6, 2015)
  • K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA (March 18, 2014)