Advia Centaur Toxoplasma IgM Assay

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Bayer Diagnostics Advia Centaur Toxoplasma Igm Assay

510(k) Number

K010755 ↗

FDA Product Code

LGD

Device Class

Class II

Regulation

21 CFR Part 866.3780

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Advia Centaur Toxoplasma IgM Assay used for?

  This assay is designed for the qualitative detection of IgM antibodies to *Toxoplasma gondii* in human serum or plasma. It helps distinguish acute or primary toxoplasmosis infections from chronic or latent cases by identifying recent exposure through IgM antibody presence. Clinicians use it in clinical microbiology labs for serological diagnosis.

• How is the Advia Centaur Toxoplasma IgM Assay supplied, and is it sterile?

  The assay is supplied as a reagent kit intended for in vitro diagnostic use. It is not sterile and is meant for single-use only, as specified by the manufacturer. Each kit contains all necessary components for one test run, ensuring no cross-contamination between samples.

• Is this device approved for clinical use, and what regulatory pathway was followed?

  Yes, the Advia Centaur Toxoplasma IgM Assay has received FDA 510(k) clearance (K010755) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class II device under FDA regulations (product code LGD) and is intended for use in clinical microbiology settings.

• What storage requirements apply to the Advia Centaur Toxoplasma IgM Assay?

  Storage instructions are detailed in the accompanying instructions provided with the kit. Generally, reagent kits like this are sensitive to temperature and humidity, so they should be stored according to the manufacturer’s guidelines—typically refrigerated (2–8°C) and protected from light until use. Always refer to the included documentation for precise storage conditions.

• Can this assay be reused, or is it intended for single-use only?

  The Advia Centaur Toxoplasma IgM Assay is explicitly intended for single-use only. Reusing components could compromise test accuracy, introduce contamination, or violate sterility requirements. Each kit is engineered for one diagnostic run, ensuring reliable and reproducible results for patient testing.