510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160819Substantially Equivalent

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

The Binding Site Group Ltd., Edgbaston, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K160819 is the FDA 510(k) clearance record for Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit, a class II device, cleared for The Binding Site Group , Ltd. on under FDA product code OPX (Immunoglobulin A Kappa Heavy & Light Chain Combined). FDA's definition for product code OPX reads: "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...". FDA records list 44 510(k) clearances for The Binding Site Group , Ltd., from to . As of , FDA records show no recalls naming K160819.

Clearance record

Decision date
Received
(84 days to decision)
Product code
OPX Immunoglobulin A Kappa Heavy & Light Chain Combined
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
The Binding Site Group , Ltd. 8 Calthorpe Rd., Edgbaston, GB
510(k) summary
Statement
Third party review
No

Clearances, product code OPX

Trailing 12 months

FDA records hold no clearances under product code OPX in the trailing twelve months.

FDA records show no clearances under product code OPX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OPX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260