Free T4 Immunoassay Kit
510(k) K900060
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900060 | Date29 Mar 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
Overview
AI-generated summary, 1 Oct 2026
The Free T4 Immunoassay Kit is a radioimmunoassay for measuring free thyroxine (T4) levels in serum or plasma. It employs immunochemical techniques to quantify the biologically active, unbound fraction of T4, a critical marker for thyroid function assessment. This device falls under the classification of a Clinical Chemistry Device, specifically designed for diagnostic in vitro use.
This kit is intended for single-use in clinical laboratory settings and requires no sterilization beyond its original packaging. It is classified as a Class II device under FDA regulations (862.1695) and holds an FDA 510(k) clearance (K900060) with a decision of Substantially Equivalent (SESE). Supplied as a complete assay system, it includes all necessary reagents and components for immediate use, with no additional preparation required beyond standard laboratory procedures.
Other devices from Advanced Magnetics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Free T4 Immunoassay Kit used for?
The Free T4 Immunoassay Kit is designed to measure free thyroxine (T4) levels in serum or plasma using immunochemical techniques. Free T4 represents the biologically active, unbound fraction of T4, making it a critical marker for assessing thyroid function in clinical laboratory settings. This kit helps clinicians diagnose and monitor thyroid disorders by providing precise quantification of this hormone.
How is the Free T4 Immunoassay Kit supplied, and what does it include?
The kit is supplied as a complete assay system, containing all necessary reagents and components required for immediate use. No additional preparation is needed beyond standard laboratory procedures. This ensures convenience and consistency in performing free T4 measurements without extra steps or materials.
Is the Free T4 Immunoassay Kit single-use or reusable?
The Free T4 Immunoassay Kit is intended for single-use only. It is designed to be used once per assay and does not require sterilization beyond its original packaging. This ensures safety, accuracy, and compliance with clinical laboratory protocols for diagnostic testing.
What regulatory clearance does the Free T4 Immunoassay Kit hold?
The Free T4 Immunoassay Kit holds an FDA 510(k) clearance (K900060) with a decision of Substantially Equivalent (SESE). It is classified as a Class II device under FDA regulations (862.1695) and is intended for in vitro diagnostic use in clinical chemistry. This clearance confirms its compliance with U.S. regulatory standards for safety and performance.
How should the Free T4 Immunoassay Kit be stored?
While the provided data does not specify storage conditions explicitly, standard laboratory practices for immunoassay kits generally recommend storing the kit in a clean, dry environment at room temperature, protected from direct light and moisture. Always refer to the included instructions or manufacturer guidelines for precise storage instructions to maintain reagent integrity and assay accuracy.