EMIT Thyroxine Assay

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K885141 ↗

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 types of samples can the EMIT Thyroxine Assay measure, and why is this important for thyroid testing?

  The EMIT Thyroxine Assay is designed to measure total thyroxine (T4), including both free and protein-bound forms, in human serum and plasma. This is important because thyroid disorders like hypothyroidism or hyperthyroidism often require assessment of overall T4 levels—not just free T4—to evaluate thyroid function comprehensively. The assay’s ability to detect both bound and unbound T4 provides a broader clinical picture for diagnosis and monitoring.

• Is the EMIT Thyroxine Assay intended for single-use, and if so, how does this affect workflow in a clinical lab?

  Yes, the EMIT Thyroxine Assay is intended for single-use per manufacturer specifications. This means each reagent kit is designed for one testing cycle, reducing the risk of cross-contamination and ensuring consistent, reliable results. For labs, this simplifies inventory management and eliminates the need for reprocessing or sterilization between uses, streamlining workflow while maintaining accuracy.

• What kind of immunoassay technology does the EMIT Thyroxine Assay use, and how does this differ from traditional radiolabeled methods?

  The EMIT Thyroxine Assay employs a non-radiolabeled enzyme immunoassay (EIA) technique, which avoids the use of radioactive materials. Unlike traditional radiolabeled assays, this method relies on enzymatic reactions to detect and quantify T4 levels, offering advantages like reduced radiation exposure for lab personnel, easier waste disposal, and potentially faster turnaround times. The non-radiolabeled approach also aligns with modern safety and regulatory preferences.

• How is the EMIT Thyroxine Assay supplied, and what should labs consider when ordering or storing it?

  The EMIT Thyroxine Assay is supplied as a reagent kit for in vitro diagnostic use in clinical chemistry laboratories. While specific storage conditions aren’t detailed in the provided data, standard laboratory practices—such as protecting from extreme temperatures, light, and contamination—should be followed. Labs should ensure the kit is stored in a controlled environment to preserve reagent integrity until use, as single-use kits require freshness for accurate results.

• What regulatory pathway did the EMIT Thyroxine Assay follow to gain market authorization, and what does this mean for its clinical use?

  The EMIT Thyroxine Assay received FDA 510(k) clearance, which means it was determined to be substantially equivalent to a legally marketed predicate device under the FDA’s traditional review process. This classification places it in Class II, indicating it carries moderate risk and is subject to special controls. Clinically, this clearance signifies that the assay meets established performance standards for measuring total T4, ensuring reliability for diagnosing and monitoring thyroid disorders in a regulated setting.