Cleared Traditional

Optilite? Freelite Mx Kappa Free Kit; Optilite? Freelite Mx Lambda Free Kit

K250549 · The Binding Site Group , Ltd. · Immunology
May 2025
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K250549 is an FDA 510(k) clearance for the Optilite? Freelite Mx Kappa Free Kit; Optilite? Freelite Mx Lambda Free Kit, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on May 23, 2025, 87 days after receiving the submission on February 25, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K250549 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2025
Decision Date May 23, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DFH — Kappa, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

Similar Devices — DFH Kappa, Antigen, Antiserum, Control

All 62
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (?) Free Light Chain Assay
K253358 · Diazyme Laboratories, Inc. · Dec 2025
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · Sebia · Feb 2024
Optilite? Freelite? Kappa Free Kit, Optilite? Freelite? Lambda Free Kit
K231290 · The Binding Site, Ltd. · Jan 2024
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · Sebia · Nov 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
K211648 · Diazyme Laboratories, Inc. · Sep 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
K220001 · Diazyme Laboratories, Inc. · Aug 2022