Tetrabead - 125 T4 Solid Phase Diag. Kit
by Abbott Laboratories 510(k)
Active
510(k) K792188
Overview
The Tetrabead 125I T4 Solid Phase Diagnostic Kit is a solid-phase radioimmunoassay device used for the quantitative measurement of total thyroxine (T4) in serum or plasma. It employs a competitive binding assay where 125I-labeled T4 and patient sample compete for binding sites on immobilized antibodies, enabling precise hormone level assessment.
This kit is intended for in vitro diagnostic use in clinical chemistry laboratories. Supplied as a single-use reagent system, it requires no sterilization beyond manufacturer-provided packaging. The device is classified under FDA product code CDX (Clinical Chemistry) and has received a Traditional 510(k) clearance (K792188) under the Special Controls for Class II devices. Storage conditions and expiration dates are specified in the accompanying instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792188 | Date27 Nov 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CDX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1700
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Tetrabead 125I T4 Solid Phase Diagnostic Kit used for?
This kit is designed for in vitro diagnostic use in clinical chemistry laboratories to quantitatively measure total thyroxine (T4) levels in serum or plasma samples. It employs a solid-phase radioimmunoassay, where 125I-labeled T4 and the patient’s sample compete for binding sites on immobilized antibodies. This competitive binding allows for precise assessment of hormone levels, aiding in the diagnosis or monitoring of thyroid function disorders.
How is the Tetrabead 125I T4 Solid Phase Diagnostic Kit supplied, and is it reusable?
The kit is supplied as a single-use reagent system, meaning each kit is intended for one diagnostic procedure only. No additional sterilization is required beyond the manufacturer-provided packaging, as it is designed for single-use to ensure accuracy and patient safety.
What storage conditions should be followed for this diagnostic kit?
Storage conditions and expiration dates are detailed in the accompanying instructions provided with the kit. These instructions specify how to preserve the kit’s integrity until use, ensuring optimal performance and reliability of the assay results.
Is this device classified under any specific regulatory category?
Yes, the Tetrabead 125I T4 Solid Phase Diagnostic Kit is classified under the FDA product code CDX, which stands for Clinical Chemistry. It has received a Traditional 510(k) clearance (K792188) under the Special Controls for Class II devices, indicating it meets regulatory standards for in vitro diagnostic use.
What type of assay does this kit utilize, and why is this important?
This kit utilizes a solid-phase radioimmunoassay (RIA), a type of competitive binding assay. In this method, 125I-labeled T4 and the patient’s sample compete for binding sites on immobilized antibodies. The importance of this technique lies in its high sensitivity and specificity for measuring hormone levels, enabling accurate diagnosis of thyroid-related conditions such as hypothyroidism or hyperthyroidism.