Advia Centaur Rubella IgG Assay

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K003412 ↗

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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• What types of laboratories can use the Advia Centaur Rubella IgG Assay, and what systems does it require?

  The Advia Centaur Rubella IgG Assay is designed exclusively for use in laboratory settings equipped with the Advia Centaur CP, XP, or XPT Immunoassay Systems. It is not intended for point-of-care or clinical point-of-use testing outside these systems.

• Is the Advia Centaur Rubella IgG Assay intended for single-use or reusable applications, and does it require sterilization?

  The assay is supplied as a single-use reagent, meaning each kit is designed for one-time use only. Since it is not reusable, no additional sterilization is required before or after use, simplifying workflow and reducing contamination risks.

• What kind of results does this assay provide, and how does it help in diagnosing rubella?

  The Advia Centaur Rubella IgG Assay uses a direct chemiluminometric microparticle immunoassay to detect and quantify IgG antibodies against the rubella virus. It provides both qualitative (presence/absence) and quantitative (levels of antibodies) results, aiding clinicians in determining whether a patient has immunity to rubella or an active infection.

• How is the regulatory status of this assay defined, and what does that mean for its use?

  The assay holds FDA 510(k) clearance (K003412) and is classified as a Class II medical device under the product code LFX. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for laboratory use in microbiology.