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TDX Immunoglobulin G Diagnostic Kit

by Abbott Laboratories 510(k)

Active United States

510(k) K872800

Overview

The TDX Immunoglobulin G Diagnostic Kit is an in vitro diagnostic device used for the quantitative measurement of Immunoglobulin G (IgG) in human serum or plasma. It employs a time-resolved fluorescence immunoassay technique to detect and quantify IgG levels, supporting the diagnosis and monitoring of immune-related conditions.

This kit is intended for single-use in clinical laboratory settings and requires no special handling for sterility beyond standard aseptic technique. It is classified under FDA product code DEW as an Immunoglobulin G antigen, antiserum, and control set, with a regulatory clearance under 21 CFR 866.5510. The device is supplied as a complete diagnostic kit and must be stored according to manufacturer instructions to maintain stability and performance.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872800 Date12 Aug 1987ClearedStatusActive

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: none on record (FDA, checked 6 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
DEW
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical conditions is the TDX Immunoglobulin G Diagnostic Kit primarily used to diagnose or monitor?

    The TDX Immunoglobulin G Diagnostic Kit is designed for the quantitative measurement of Immunoglobulin G (IgG) in human serum or plasma, supporting the diagnosis and monitoring of immune-related conditions. This includes conditions where IgG levels may be clinically relevant, such as primary immunodeficiencies, autoimmune disorders, or other immunologic evaluations.

  • Is the TDX Immunoglobulin G Diagnostic Kit intended for single-use or can it be reused?

    The TDX Immunoglobulin G Diagnostic Kit is explicitly intended for single-use in clinical laboratory settings. It is not designed or cleared for reuse, so each kit should be used once and then discarded.

  • What type of assay does the TDX Immunoglobulin G Diagnostic Kit use, and how does it work?

    The kit employs a time-resolved fluorescence immunoassay technique to detect and quantify IgG levels. This method uses fluorescent markers to measure the binding of IgG antibodies in the sample, providing a precise quantitative result for clinical interpretation.

  • How should the TDX Immunoglobulin G Diagnostic Kit be stored to ensure stability and accuracy?

    The kit must be stored according to the manufacturer’s instructions to maintain stability and performance. While the data does not specify exact storage conditions (e.g., temperature), standard practice for immunoassay kits typically requires refrigeration (2–8°C) and protection from light until use.

  • What regulatory pathway was followed for the clearance of the TDX Immunoglobulin G Diagnostic Kit?

    The TDX Immunoglobulin G Diagnostic Kit received FDA clearance via a 510(k) submission, classified under 21 CFR 866.5510 as an Immunoglobulin G antigen, antiserum, and control set. The submission was reviewed by the Immunology (IM) Advisory Committee and determined to be substantially equivalent to a predicate device, with a traditional clearance process.