Thyroxine (FPIA) Kit
by Tudor Laboratories, Inc. 510(k)
Active
510(k) K921904
Overview
This device is an Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine kit designed for the quantitative measurement of total thyroxine (T4) in serum or plasma using Fluorescence Polarization Immunoassay (FPIA) technology. It is classified as a Class II medical device under FDA regulations (21 CFR 862.1700) and is intended for use in clinical chemistry laboratories to aid in the diagnosis and monitoring of thyroid function disorders.
The Thyroxine (FPIA) Kit is supplied as a single-use diagnostic reagent system and requires no sterilization beyond its manufacturer-provided packaging. It is intended for use in laboratory settings with appropriate instrumentation, such as fluorescence polarization immunoassay analyzers. The kit includes all necessary reagents and calibrators for performing tests on samples, with no additional preparation required beyond standard laboratory procedures. FDA clearance (510(k) K921904) was granted under the Traditional 510(k) review pathway, with the device deemed Substantially Equivalent to a predicate.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921904 | Date24 Jun 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KLI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1700
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tudor Laboratories, Inc.
Questions
What is the Thyroxine (FPIA) Kit used for?
The Thyroxine (FPIA) Kit is designed for the quantitative measurement of total thyroxine (T4) in serum or plasma samples. It uses Fluorescence Polarization Immunoassay (FPIA) technology to aid in diagnosing and monitoring thyroid function disorders, such as hypothyroidism or hyperthyroidism, in clinical chemistry laboratory settings.
How is the Thyroxine (FPIA) Kit supplied, and is it sterile?
The kit is supplied as a single-use diagnostic reagent system, fully packaged by the manufacturer. No additional sterilization is required beyond the manufacturer-provided packaging, as it is intended for one-time use in laboratory settings.
Does this kit require special equipment or additional preparation?
The kit is intended for use with fluorescence polarization immunoassay analyzers in clinical chemistry laboratories. It includes all necessary reagents and calibrators, so no additional preparation is required beyond standard laboratory procedures.
Is the Thyroxine (FPIA) Kit reusable, or is it designed for single-use?
The kit is explicitly designed for single-use only. Each kit is intended for one testing session, ensuring accuracy and preventing cross-contamination in laboratory environments.
What regulatory pathway was followed for FDA clearance of this device?
The Thyroxine (FPIA) Kit received FDA clearance under the Traditional 510(k) review pathway, with the device deemed Substantially Equivalent to a predicate. This clearance was granted on June 24, 1992, under the classification of Class II medical device (21 CFR 862.1700).