IMX Free T4
by Abbott Laboratories 510(k)
Active
510(k) K902834
Overview
The IMX Free T4 is a radioimmunoassay device for measuring free thyroxine (T4) levels in serum or plasma. It employs immunometric techniques to quantify unbound thyroxine, a critical thyroid hormone, enabling clinical assessment of thyroid function and metabolic disorders. This assay provides precise diagnostic support for conditions such as hyperthyroidism, hypothyroidism, and pituitary-thyroid axis dysfunctions.
This device is intended for use in clinical chemistry laboratories and requires proper handling as a single-use diagnostic reagent. Supplied in sterile, pre-packaged kits, it adheres to FDA 510(k) clearance (K902834) and Class II regulatory classification (product code CEC). Storage conditions include refrigeration (2–8°C) and protection from light, with expiration dates clearly marked on packaging. No MRI safety considerations apply, as it is not a magnetic resonance-compatible device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902834 | Date7 Sep 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1131-03
The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.
Specification
- Full name
- Abbott Imx Free T4
- 510(k) Number
- FDA Product Code
- CEC
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1695
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What clinical conditions does the Abbott IMX Free T4 assay support diagnosis of?
The Abbott IMX Free T4 assay quantifies unbound thyroxine (T4) in serum or plasma, enabling clinical assessment of thyroid function. It provides diagnostic support for conditions such as hyperthyroidism, hypothyroidism, and dysfunctions of the pituitary-thyroid axis. By measuring free T4 levels, clinicians can evaluate metabolic disorders linked to thyroid hormone imbalance.
How is the Abbott IMX Free T4 device supplied, and is it reusable?
The Abbott IMX Free T4 is supplied in sterile, pre-packaged kits designed for single-use only. Each kit contains the necessary reagents for one diagnostic test, ensuring consistency and sterility. Reuse is not recommended or intended, as it could compromise accuracy and patient safety.
What storage conditions are required for the Abbott IMX Free T4 assay?
The device must be stored refrigerated between 2–8°C and protected from light to maintain stability and integrity. Proper storage is critical to preserve the assay’s performance and prevent degradation of the reagents. Always check the expiration date on the packaging before use.
Does the Abbott IMX Free T4 device have any special handling or safety considerations?
No MRI safety considerations apply to the Abbott IMX Free T4, as it is not a magnetic resonance-compatible device. However, it is intended for use in clinical chemistry laboratories and requires proper handling as a single-use diagnostic reagent. Adherence to sterile techniques and storage guidelines is essential for accurate results.
What regulatory clearance does the Abbott IMX Free T4 hold?
The Abbott IMX Free T4 holds FDA 510(k) clearance under the classification of Class II medical devices, with the clearance number K902834. This regulatory status indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for measuring free thyroxine levels.