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Alinity i Rubella IgG

by Abbott Laboratories 510(k)

Active United States

510(k) K243168

Overview

The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of IgG antibodies to rubella present in a sample. This test detects IgG antibodies the immune system makes after vaccination or past infection to rubella virus.

The device is supplied as a reagent kit for use with the Alinity i System and contains 200 tests. It is a non-waived test that requires blood-serum samples. The device is FDA 510(k) cleared with product code LFX and is intended for in vitro diagnostic use in clinical laboratories.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243168 Date20 Jun 2025ClearedStatusActive

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 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
LFX
Device Class
Class II
Regulation
21 CFR Part 866.3510
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Alinity i Rubella IgG assay used for?

    The Alinity i Rubella IgG assay is a chemiluminescent microparticle immunoassay used for the quantitative determination of IgG antibodies to rubella present in a sample. It detects IgG antibodies the immune system makes after vaccination or past infection to rubella virus.

  • How is the Alinity i Rubella IgG assay supplied?

    The device is supplied as a reagent kit for use with the Alinity i System and contains 200 tests. It is a non-waived test that requires blood-serum samples for in vitro diagnostic use in clinical laboratories.

  • What is the regulatory status of the Alinity i Rubella IgG assay?

    The device is FDA 510(k) cleared with product code LFX. It has been determined to be substantially equivalent to predicate devices and is intended for in vitro diagnostic use in clinical laboratories.

  • Is the Alinity i Rubella IgG assay reusable or single-use?

    The Alinity i Rubella IgG assay is supplied as a reagent kit containing 200 tests, indicating it is designed for multiple uses within the kit. However, individual test samples are processed once and not reused.