510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K140105Substantially Equivalent

Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii

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

K140105 is the FDA 510(k) clearance record for HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII, a class II device, cleared for The Binding Site 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 125 510(k) clearances for The Binding Site, from to . As of , FDA records show no recalls naming K140105.

Clearance record

Decision date
Received
(62 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 8 Calthorpe Rd., Birmingham, 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