125 I-T4 RIA Test Kit
by Intl. Immunoassay Laboratories, Inc. 510(k)
Active
510(k) K811070
Overview
This device is a radioimmunoassay test kit for total thyroxine (T4). It is used to measure T4 levels in serum or plasma samples through a competitive binding assay using iodine-125 labeled tracer.
The kit is supplied for in vitro diagnostic use in clinical laboratory settings. It is classified as a Class II device under regulation 862.1700 with product code CDX, and received FDA 510(k) clearance as substantially equivalent on April 29, 1981.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811070 | Date29 Apr 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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 Intl. Immunoassay Laboratories, Inc.
Questions
What is the 125 I-T4 RIA TEST KIT used for?
The 125 I-T4 RIA TEST KIT is used to measure total thyroxine (T4) levels in serum or plasma samples through a competitive binding assay that employs an iodine-125 labeled tracer, enabling quantitative assessment of thyroid function in clinical laboratory settings.
How is the 125 I-T4 RIA TEST KIT supplied and intended for use?
The kit is supplied for in vitro diagnostic use in clinical laboratory settings, containing all necessary components for performing the radioimmunoassay to measure T4 levels in human serum or plasma specimens, and is not intended for point-of-care or home use.
Is the 125 I-T4 RIA TEST KIT a single-use or reusable device?
The 125 I-T4 RIA TEST KIT is designed for single-use per test run, as the radioactive iodine-125 tracer and associated reagents are consumed during the assay and cannot be safely reused due to degradation, contamination risk, and loss of signal integrity.
What regulatory pathway was used for the 125 I-T4 RIA TEST KIT?
The device received FDA 510(k) clearance as substantially equivalent on April 29, 1981, under regulation 862.1700 with product code CDX, following a traditional review pathway based on its similarity to legally marketed predicate devices.