Abbott IMX T4
by Abbott Laboratories 510(k)
Active
510(k) K925110
Overview
The Abbott IMX T4 is a radioimmunoassay device for measuring total thyroxine (T4) levels in serum or plasma. It employs immunometric techniques to quantify free and protein-bound thyroxine, aiding in the diagnosis and monitoring of thyroid disorders, including hypothyroidism and hyperthyroidism. As a Clinical Chemistry instrument, it provides quantitative results essential for endocrinological assessments.
The IMX T4 is intended for use in clinical laboratory settings and is supplied as a single-use reagent system for automated immunoassay analyzers. It is classified under FDA 510(k) clearance (K925110) as a Class II device under product code CDX, with regulatory approval granted in 1993. Storage and handling follow standard immunoassay protocols, ensuring accuracy and sterility for diagnostic use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925110 | Date26 Jan 1993 | 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- Withdrawn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 Abbott IMX T4 used for?
The Abbott IMX T4 is a radioimmunoassay device designed to measure total thyroxine (T4) levels in serum or plasma. It quantifies both free and protein-bound thyroxine, supporting the diagnosis and ongoing management of thyroid conditions such as hypothyroidism and hyperthyroidism. Clinicians rely on these quantitative results for accurate endocrinological assessments.
How is the Abbott IMX T4 supplied and intended for use?
The Abbott IMX T4 is supplied as a single-use reagent system specifically for automated immunoassay analyzers in clinical laboratory settings. This design ensures consistency and reduces contamination risks, as each reagent kit is intended for one-time use only. It integrates seamlessly with automated systems to streamline workflows while maintaining diagnostic precision.
Is the Abbott IMX T4 sterile and how should it be stored?
The Abbott IMX T4 is supplied in a sterile format, adhering to standard immunoassay protocols to preserve sterility and accuracy. Storage should follow manufacturer guidelines, typically involving refrigeration (e.g., 2–8°C) and protection from light and moisture. Proper storage conditions are critical to maintaining reagent integrity and ensuring reliable test results.
What regulatory approval does the Abbott IMX T4 hold?
The Abbott IMX T4 holds FDA 510(k) clearance (K925110) under product code CDX, classified as a Class II device. This clearance was granted in 1993 and confirms its substantial equivalence to a predicate device, ensuring compliance with U.S. regulatory standards for clinical chemistry instruments. The device is also listed under OpenFDA with multiple registration numbers.
Are there different models or sizes available for the Abbott IMX T4?
The Abbott IMX T4 is primarily offered as a standardized reagent system for automated analyzers, with no explicit mention of multiple models or sizes in the available data. However, the device is associated with multiple registration numbers (e.g., 3009335633, 3017379203), which may reflect variations in reagent kits or lot-specific configurations. Clarification on specific variants should be directed to Abbott Laboratories.