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Human BETA-2 Microglobulin Kit

by The Binding Site, Ltd. 510(k)

Active United States

510(k) K083289

Overview

The Human Beta-2 Microglobulin Kit is an immunological test system designed to measure beta-2-microglobulin in serum, urine, and other body fluids using immunochemical techniques. Beta-2-microglobulin is a protein molecule whose levels can be clinically relevant in assessing renal function, monitoring certain cancers, and evaluating immune system activity.

This kit is intended for in vitro diagnostic use and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device under regulation 866.5630. It is supplied as a reagent-based system for laboratory analysis and is not intended for MRI use or direct patient administration. The kit is distributed by The Binding Site, Ltd., and its specifications align with immunology testing protocols.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083289 Date6 May 2009ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JZG
Device Class
Class II
Regulation
21 CFR Part 866.5630
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the purpose of the Human Beta-2 Microglobulin Kit?

    The kit is designed to measure beta-2-microglobulin levels in serum, urine, and other body fluids using immunochemical techniques, which can be clinically relevant for assessing renal function, monitoring certain cancers, and evaluating immune system activity.

  • How is the Human Beta-2 Microglobulin Kit supplied?

    The kit is supplied as a reagent-based system for laboratory analysis, distributed by The Binding Site, Ltd., and is intended for in vitro diagnostic use only.

  • What regulatory pathway has the Human Beta-2 Microglobulin Kit undergone?

    The kit has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device under regulation 866.5630, and was determined to be substantially equivalent.

  • Is the Human Beta-2 Microglobulin Kit intended for single-use or multiple uses?

    The device is supplied as a reagent-based system for laboratory analysis, and while the data does not explicitly state single-use or reuse, it is designed for in vitro diagnostic testing in laboratory settings.