Technicon Ra-1000 Sys T4-Thyroxine

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841576 ↗

FDA Product Code

KLI

Device Class

Class II

Regulation

21 CFR Part 862.1700

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Technicon RA-1000 System T4-Thyroxine used for?

  The Technicon RA-1000 System T4-Thyroxine is an enzyme immunoassay device designed to measure total thyroxine (T4) levels in serum samples. It provides quantitative results to help clinicians assess thyroid function and diagnose thyroid-related disorders, such as hypothyroidism or hyperthyroidism. The system is integrated into the Technicon RA-1000 modular clinical chemistry analyzer, enabling automated and precise testing in laboratory settings.

• How is the Technicon RA-1000 System T4-Thyroxine supplied, and is it single-use?

  The device is supplied as part of the Technicon RA-1000 System, which is a modular clinical chemistry analyzer. The system uses disposable reagents and consumables, meaning each test run requires fresh materials, though the analyzer itself is reusable. This design ensures single-use applications for reagents and consumables, reducing cross-contamination risks in laboratory workflows.

• Is sterility or MRI safety information provided for the Technicon RA-1000 System T4-Thyroxine?

  The available data for the Technicon RA-1000 System T4-Thyroxine does not include specific details regarding sterility or MRI safety. Clinicians should follow standard laboratory protocols for handling non-sterile immunoassay devices and ensure the analyzer is used in environments where MRI compatibility is not required, as no such information is provided.

• What regulatory pathway was followed for the clearance of this device?

  The Technicon RA-1000 System T4-Thyroxine was cleared through the Traditional 510(k) pathway by the FDA in 1984. It is classified as a Class 2 device under FDA regulations, with the product code KLI (Clinical Laboratory Reagents). The clearance was based on a determination of substantial equivalence to a predicate device, as outlined in the submission.

• Are there different models or sizes available for the Technicon RA-1000 System T4-Thyroxine?

  The provided data specifies the Technicon RA-1000 System T4-Thyroxine as a single, modular component of the broader Technicon RA-1000 clinical chemistry analyzer system. While the system itself is modular and capable of performing multiple assays, the T4-Thyroxine module is not described as having multiple models or sizes. Users rely on the analyzer’s integrated capabilities for testing.