Dac-Cel T3
by Burroughs Wellcome Co. 510(k)
Active
510(k) K791232
Overview
The DAC-CEL T3 is a radioimmunoassay kit designed for the quantitative measurement of total triiodothyronine (T3) in serum or plasma. It employs radioisotopic techniques to detect and quantify T3 levels, enabling clinical assessment of thyroid function. This device falls under the classification of diagnostic assays, specifically for endocrine system evaluation.
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 regulated under FDA 510(k) clearance (K791232) and falls under product code CDP, adhering to Class II special controls. Storage and handling follow standard radioisotope safety protocols, as it contains radioactive materials.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791232 | Date4 Sep 1979 | 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- Withdrawn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
- CDP
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1710
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Burroughs Wellcome Co.
Questions
What is the DAC-CEL T3 kit used for?
The DAC-CEL T3 is a radioimmunoassay kit designed specifically for the quantitative measurement of total triiodothyronine (T3) in serum or plasma samples. It helps clinicians assess thyroid function by providing accurate T3 levels, which are critical for diagnosing and monitoring endocrine disorders related to the thyroid gland.
How is the DAC-CEL T3 kit supplied, and is it reusable?
The DAC-CEL T3 kit is supplied as a single-use reagent system. It is not intended for reuse, as radioimmunoassay kits typically contain sensitive reagents that degrade with repeated use. Each kit is packaged to ensure sterility and safety for one-time diagnostic testing.
Does the DAC-CEL T3 kit require sterilization beyond its packaging?
No, the DAC-CEL T3 kit does not require additional sterilization beyond what the manufacturer provides in its packaging. The kit is designed for in vitro diagnostic use and is pre-sterilized to ensure safety for clinical laboratory procedures.
What safety precautions should be taken when handling the DAC-CEL T3 kit?
The DAC-CEL T3 kit contains radioactive materials, so it must be handled following standard radioisotope safety protocols. This includes proper shielding, disposal procedures, and adherence to laboratory guidelines for managing radioactive substances to minimize exposure risks.
What regulatory pathway does the DAC-CEL T3 kit follow?
The DAC-CEL T3 kit is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K791232. It falls under product code CDP and is classified as a Class II device with special controls, ensuring it meets stringent standards for diagnostic accuracy and safety in clinical chemistry.