Vidas FT4

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

510(k) Number

K132058 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomerieux S.A. →

• What clinical purpose does the VIDAS FT4 serve in thyroid function assessment?

  The VIDAS FT4 is designed for the quantitative measurement of free thyroxine (FT4) in human serum or plasma, supporting the diagnosis and monitoring of thyroid disorders such as hypothyroidism and hyperthyroidism. By providing precise FT4 levels, it aids clinicians in evaluating thyroid function within clinical chemistry workflows.

• Is the VIDAS FT4 system reusable, and what consumables are required for operation?

  Yes, the VIDAS FT4 is supplied as a reusable analytical platform. It requires single-use disposable reagents and consumables to perform immunoassay measurements, ensuring accuracy and compliance with clinical laboratory protocols.

• How should the VIDAS FT4 be stored to maintain its performance integrity?

  The VIDAS FT4 must be stored according to the manufacturer’s instructions, which specify conditions to preserve its functionality. While exact details aren’t provided, adherence to these guidelines is critical to avoid degradation and ensure reliable FT4 measurement results.

• What regulatory pathways does the VIDAS FT4 follow, and where is it cleared or authorized?

  The VIDAS FT4 has received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent (SESE) to a predicate device. It also complies with the In Vitro Diagnostic Regulation (IVDR), indicating its authorization for use in clinical laboratories under both U.S. and EU regulatory frameworks.

• Are there specific model variations or sizes available for the VIDAS FT4 system?

  The provided data does not specify distinct model variations or sizes for the VIDAS FT4 system itself, but it is designed as a reusable analytical platform with single-use consumables tailored for immunoassay testing. For precise configurations, refer to the manufacturer’s documentation or technical specifications.