Immunochemical Determination of Immunoglobulin M

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K884147 ↗

FDA Product Code

DFT

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Orion Diagnostica, Inc. →

• What is the Immunochemical Determination of Immunoglobulin M device used for?

  This device is used for the detection and quantification of immunoglobulin M (IgM) in clinical specimens. It functions as an antigen, antiserum, or control reagent within immunoassay systems to support immunology testing in laboratory settings.

• How is the Immunoglobulin M determination reagent supplied and intended for use?

  The device is supplied as a reagent for in vitro diagnostic use and is intended for use in immunology laboratory settings. It is not a standalone test but serves as a component—such as an antigen, antiserum, or control—within broader immunoassay systems for IgM detection and quantification.

• Is the Immunochemical Determination of Immunoglobulin M reagent reusable or single-use?

  The device data does not specify whether the reagent is single-use or reusable. As a reagent for in vitro diagnostic use, its usability depends on the specific formulation and manufacturer's instructions, which are not detailed in the provided information. Users should consult the product labeling for reuse guidelines.

• What regulatory pathway was used for the Immunoglobulin M determination device?

  The device received FDA 510(k) clearance under submission K884147 on October 27, 1988, based on a determination of substantial equivalence. It is classified as a Class II medical device under regulation 866.5550, with product code DFT, and was reviewed by the Immunology advisory committee.