Total T4 FPIA Reagent Set/Calibrator #T-1039, T-116

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

510(k) Number

K932980 ↗

FDA Product Code

CDX

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 Total T4 FPIA Reagent Set/Calibrator used for in clinical practice?

  This reagent set is designed for the quantitative measurement of total thyroxine (T4) levels in serum or plasma samples. It uses fluorescent polarization immunoassay (FPIA) technology to help diagnose and monitor thyroid disorders, such as hypothyroidism and hyperthyroidism, by providing accurate hormone level readings in clinical chemistry laboratories.

• Is the Total T4 FPIA Reagent Set intended for single-use or repeated use?

  The Total T4 FPIA Reagent Set is explicitly labeled for single-use only. Reusing the reagent set could compromise accuracy and reliability, so it must be discarded after one use to maintain proper testing standards.

• How should the Total T4 FPIA Reagent Set be stored to ensure optimal performance?

  The manufacturer’s guidelines must be followed for storage, though the data specifies it is a single-use reagent set—typically, such assays require refrigeration (e.g., 2–8°C) and protection from light until use. Always check the included instructions for precise storage conditions to preserve stability and accuracy.

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

  The Total T4 FPIA Reagent Set received FDA 510(k) clearance (K932980) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to a predicate device. It was classified as a Class II medical device under product code CDX (Clinical Chemistry) and reviewed by the Clinical Chemistry (CH) Advisory Committee.

• Are there multiple models or sizes available for this reagent set?

  The data lists two specific product identifiers (#T-1039 and #T-116), suggesting these may represent different lot numbers, calibrator versions, or minor revisions of the reagent set. However, no distinct sizes or models are described—it is supplied as a single reagent set with calibrators for total T4 measurement, so compatibility should be verified with laboratory systems.