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Radioassay for Total Serum Thyroxine

FDA 510(k)

Class II (US FDA 510(k))

510(k) K780644

by Nuclear Diagnostics, Inc.

Identifiers

510(k) Number
K780644 FDA 510(k)
FDA Product Code
CDX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1700 FDA 510(k)
Regulation Number
862.1700 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a radioimmunoassay for measuring total thyroxine (T4) levels in serum, classified under FDA product code CDX (Clinical Chemistry). It employs radiolabeled antibody competition to quantify T4 concentrations, aiding in the diagnosis and monitoring of thyroid function disorders such as hypothyroidism and hyperthyroidism.

The Radioassay for Total Serum Thyroxine is intended for in vitro use in clinical laboratories. Supplied as a single-use diagnostic kit, it requires FDA clearance (510(k) K780644) and falls under 21 CFR 862.1700. No information regarding sterility, MRI safety, or reusable components is provided in the specifications. Storage and handling conditions are not detailed beyond standard laboratory protocols.

Frequently asked questions

What is the primary purpose of the Radioassay for Total Serum Thyroxine, and how does it work in a clinical setting?

This device measures total thyroxine (T4) levels in serum to aid in diagnosing and monitoring thyroid function disorders like hypothyroidism and hyperthyroidism. It uses a radioimmunoassay technique, where radiolabeled antibodies compete with T4 in the patient’s serum to bind to antibodies, allowing for precise quantification of T4 concentrations in vitro within clinical laboratories.

Is this kit designed for single-use or repeated use, and what does that mean for my lab’s workflow?

The Radioassay for Total Serum Thyroxine is explicitly supplied as a single-use diagnostic kit, meaning each kit is intended for one test procedure only. This design ensures consistency and reliability per test while reducing contamination risks, though your lab must follow standard laboratory protocols for handling and disposal to maintain workflow efficiency.

What regulatory pathway was followed for this device’s clearance, and how does that affect its use in the U.S.?

The device received FDA clearance via a 510(k) submission (K780644) under the Traditional clearance type, determined to be *substantially equivalent* to a predicate device. This means it complies with 21 CFR 862.1700 and is legally authorized for in vitro clinical chemistry use in U.S. laboratories, though no additional sterility or reuse claims are made.

Are there multiple versions or sizes of this kit, and how would I identify the correct one for my lab’s needs?

The provided data lists multiple registration numbers (e.g., 3009335633, 3002800697) associated with this device, which may correspond to different lot or variant configurations. While no explicit size or model distinctions are detailed, these identifiers could help verify compatibility with your lab’s existing systems or supplier records. Confirm with the manufacturer if specific lot-specific requirements apply.

What storage or handling precautions should I consider for this kit, given the lack of detailed specifications?

Since no specific storage conditions are provided beyond ‘standard laboratory protocols,’ it’s critical to follow general guidelines for radioassay kits: store in a cool, dry place (2–8°C) away from direct light, and protect from contamination or physical damage. Ensure proper shielding for radioactive components, and adhere to your facility’s radiation safety protocols to maintain accuracy and compliance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RADIOASSAY FOR TOTAL SERUM THYROXINE 510(k) K780644 - FDA.report, FDA Product Code CDX - Radioimmunoassay, Total Thyroxine | 510 (k ..., Nuclear Diagnostics, Inc. · DeviceClearance, Human Thyroxine, Total (T4) ELISA | BioVendor R&D

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nuclear Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K780644 24 fields · synced Sep 19, 2026