Thyroxine Stds. in Human Serum

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K780050 ↗

FDA Product Code

CDX

Device Class

Class II

Regulation

21 CFR Part 862.1700

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

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• What is the Thyroxine Standards in Human Serum used for?

  This device serves as a reference material for calibrating and validating radioimmunoassay (RIA) procedures used to measure total thyroxine (T4) levels in human serum. Accurate calibration with these standards ensures reliable quantification of T4, which is critical for diagnosing and monitoring thyroid function disorders such as hypothyroidism and hyperthyroidism. It is specifically designed for in vitro diagnostic use within clinical chemistry assay systems.

• How is the Thyroxine Standards in Human Serum supplied?

  The Thyroxine Standards in Human Serum are supplied as part of a clinical chemistry assay system. They are provided as non-sterile reference materials, meaning they are not intended for direct patient administration or sterile procedures. The product is intended for laboratory use only, where precise calibration of diagnostic assays is required.

• Is the Thyroxine Standards in Human Serum single-use or reusable?

  This product is not single-use; it is intended for repeated use in laboratory settings as a reference standard for calibrating radioimmunoassay procedures. Since it is a non-sterile reference material, it is not designed for direct patient contact or repeated use in sterile environments. Proper handling and storage are essential to maintain its integrity for calibration purposes.

• What regulatory pathway does the Thyroxine Standards in Human Serum follow?

  The Thyroxine Standards in Human Serum is authorized under the FDA’s 510(k) clearance process, specifically under clearance number K780050. It is classified under the Clinical Chemistry advisory committee (CH) and falls under FDA Product Code CDX. The device is deemed substantially equivalent to a predicate device, meaning it meets the regulatory requirements for safety and effectiveness as determined by the FDA.

• Are there any specific storage instructions for the Thyroxine Standards in Human Serum?

  The provided regulatory data does not specify detailed storage conditions for the Thyroxine Standards in Human Serum. However, as with most reference materials, it is generally recommended to store the product in a clean, dry environment, protected from extreme temperatures and light. For optimal performance, follow the manufacturer’s guidelines, which may be available in accompanying documentation or directly from Pcl-Ria, Inc.