Labeled Human Chorionic Gonadotrophin

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

510(k) Number

K790876 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

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 types of samples can this diagnostic reagent detect human chorionic gonadotropin (HCG) in, and how is it typically used in a clinical setting?

  This labeled human chorionic gonadotropin diagnostic reagent is designed for the qualitative detection of HCG in both urine and serum samples, making it versatile for pregnancy testing. It is intended for use in clinical chemistry laboratories and requires a prescription, meaning it is administered under medical supervision. The reagent visually indicates the presence of HCG, helping clinicians confirm pregnancy status based on hormone levels.

• Is this device single-use, and if so, how should it be stored to maintain its integrity?

  Yes, this diagnostic reagent is single-use only, meaning each unit is intended for one test. Since no sterility specifications are mentioned in the data, storage should follow standard laboratory protocols for prescription-use diagnostic reagents—typically in a cool, dry place, protected from direct sunlight and extreme temperatures. Always check the manufacturer’s instructions for specific storage guidelines, as improper handling could compromise accuracy.

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

  This device received FDA 510(k) clearance under the product code JHI, classified as substantially equivalent to a predicate device. The clearance was granted in 1979 through a traditional 510(k) review by the Clinical Chemistry (CH) Advisory Committee. While this confirms its compliance with FDA standards for qualitative pregnancy HCG detection, its use remains restricted to prescription-only clinical chemistry laboratories, ensuring controlled and supervised testing.

• Are there multiple models or sizes available for this diagnostic reagent, or is it supplied in a standardized format?

  The data does not specify distinct models or sizes for this labeled human chorionic gonadotropin reagent. However, the OpenFDA registration numbers suggest multiple lot-specific or batch-specific identifiers (e.g., 3013332582, 3003102569), which may correspond to different production batches rather than physical variations. Clinicians should confirm the exact format (e.g., test strips, cassettes) with the manufacturer, as the visual detection method may vary by supplier.