510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152389Substantially Equivalent

Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit

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

K152389 is the FDA 510(k) clearance record for Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit, a class II device, cleared for The Binding Site Group , Ltd. on under FDA product code PDE (Immunoglobulin M Kappa Heavy And Light Chain Combined). FDA's definition for product code PDE reads: "Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings". FDA records list 44 510(k) clearances for The Binding Site Group , Ltd., from to . As of , FDA records show no recalls naming K152389.

Clearance record

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

Clearances, product code PDE

Trailing 12 months

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

FDA records show no clearances under product code PDE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDE, 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