1-125 Labeled Triiodothyronine (T3)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K803180 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Human Follicle Stimulating Hormone

  Class I

  FDA 510(k) K780016 Active Cleared 3 Feb 1978

• Luteinizing Hormone

  Class I

  FDA 510(k) K810741 Active Cleared 31 Mar 1981

• B-GCG System by RIA

  Class II

  FDA 510(k) K830526 Active Cleared 5 Apr 1983

• Thyroid Stimulating Hormone

  Class II

  FDA 510(k) K822935 Active Cleared 1 Nov 1982

• Follicle Stimulating Hormone (Fsh)

  Class II

  FDA 510(k) K810867 Active Cleared 14 Apr 1981

• Rabbit Antibody to Digoxin

  Class II

  FDA 510(k) K780316 Active Cleared 17 Mar 1978

See all devices from Pcl-Ria, Inc. →

• What is the primary clinical use of the 1-125 Labeled Triiodothyronine (T3) reagent in a lab setting?

  This reagent is designed for measuring total triiodothyronine (T3) levels in serum or plasma using a radioimmunoassay (RIA) method. By employing a radiolabeled T3 tracer bound to antibodies, it quantifies endogenous T3 through competitive displacement, helping clinicians assess thyroid function. It’s specifically intended for in vitro diagnostic use in clinical chemistry laboratories.

• Is this device meant for single-use or repeated use, and does it require sterilization beyond its packaging?

  The 1-125 Labeled Triiodothyronine (T3) is explicitly supplied for single-use only. The manufacturer’s packaging is intended to provide the necessary sterility, so no additional sterilization is required beyond what is provided with the device.

• How should this reagent be stored, and where can I find detailed storage instructions?

  Storage conditions and shelf life are outlined in the accompanying instructions for use provided by the manufacturer. While the exact details aren’t repeated here, these instructions typically include guidance on temperature, light exposure, and expiration dates to ensure reagent integrity.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

  The device received FDA 510(k) clearance (K803180) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to a legally marketed predicate device in radioimmunoassay applications. This clearance confirms its compliance with FDA regulations for in vitro diagnostic use, ensuring it meets safety and performance standards for measuring T3 levels in clinical chemistry labs.