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Immunoglobulin M Test System

by The Binding Site, Ltd. 510(k)

Active United States

510(k) K881828

Overview

The Immunoglobulin M Test System is a radioimmunoassay device used for the measurement of immunoglobulins G, A, and M. It is classified under the immunology specialty and is designed for laboratory use in assessing immune function.

The device is supplied as a test system for in vitro diagnostic use and is regulated as a Class II medical device with product code CFQ. It received FDA 510(k) clearance (K881828) on June 6, 1988, and is substantially equivalent to a legally marketed predicate device. The system is intended for use in clinical laboratory settings and is not described as sterile, single-use, or reusable in the provided data.

AI-generated from registry data, 27 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 NumberK881828 Date6 Jun 1988ClearedStatusActive

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
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  • 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
CFQ
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Immunoglobulin M Test System used for?

    The Immunoglobulin M Test System is a radioimmunoassay device used for the measurement of immunoglobulins G, A, and M to assess immune function in clinical laboratory settings.

  • How is the Immunoglobulin M Test System supplied and intended for use?

    The device is supplied as a test system for in vitro diagnostic use and is designed for laboratory use in clinical settings to measure immunoglobulins G, A, and M.

  • Is the Immunoglobulin M Test System sterile, single-use, or reusable?

    The provided data does not describe the Immunoglobulin M Test System as sterile, single-use, or reusable; no information on sterility or reuse is included in the device specifications.

  • What regulatory pathway was used for the Immunoglobulin M Test System?

    The Immunoglobulin M Test System received FDA 510(k) clearance (K881828) on June 6, 1988, and is classified as a Class II medical device with product code CFQ.