IMX Free Triiodothyronine (Free T3)
by Abbott Laboratories 510(k)
Active
510(k) K963833
Overview
The IMX Free Triiodothyronine (Free T3) is an immunoassay device used for quantifying free triiodothyronine (free T3) levels in serum or plasma. Free T3 is a form of thyroid hormone that plays a critical role in regulating metabolism, growth, and development. This device employs a chemiluminescent immunoassay method to provide accurate measurements of free T3 concentrations, aiding in the diagnosis and monitoring of thyroid disorders such as hyperthyroidism and hypothyroidism.
The IMX Free Triiodothyronine (Free T3) is intended for use in clinical chemistry laboratories and is supplied as a reagent kit for in vitro diagnostic testing. It is classified as a Class II device under FDA regulations (862.1710) and has received FDA 510(k) clearance (K963833) as substantially equivalent to a predicate device. The assay is designed for single-use and requires proper storage at controlled temperatures to maintain performance. No specific MRI safety information is provided, and the device is not intended for reusable applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963833 | Date30 Oct 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
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 Abbott Laboratories
Questions
What is the primary use of the IMX Free Triiodothyronine (Free T3) device in clinical settings?
The IMX Free Triiodothyronine (Free T3) device is designed for quantifying free triiodothyronine levels in serum or plasma samples using a chemiluminescent immunoassay method. This helps clinicians diagnose and monitor thyroid disorders, such as hyperthyroidism and hypothyroidism, by measuring the active form of thyroid hormone involved in metabolism, growth, and development.
How is the IMX Free Triiodothyronine (Free T3) device supplied, and is it intended for single-use?
The device is supplied as a reagent kit for in vitro diagnostic testing in clinical chemistry laboratories. According to the manufacturer, it is explicitly designed for single-use only, meaning each kit is intended for one test cycle and should not be reused.
What storage conditions are required to maintain the performance of the IMX Free Triiodothyronine (Free T3) reagent kit?
The device requires controlled temperature storage to preserve its performance, though the exact temperature range isn’t specified in the provided data. Since it’s a single-use immunoassay kit, proper handling and storage per manufacturer guidelines are critical to ensure accurate test results.
Is this device approved for use outside of clinical chemistry laboratories, and what regulatory pathway was followed?
The IMX Free Triiodothyronine (Free T3) is intended exclusively for use in clinical chemistry laboratories as an in vitro diagnostic test. It received FDA 510(k) clearance (K963833) under the Traditional pathway, demonstrating substantial equivalence to a predicate device, and is classified as a Class II device under FDA regulations (862.1710).