B-GCG System by RIA

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

510(k) Number

K830526 ↗

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

• 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

• Thyroxine (T4) 125I

  Class II

  FDA 510(k) K812666 Active Cleared 2 Oct 1981

See all devices from Pcl-Ria, Inc. →

• What is the B-GCG System by RIA used for?

  The B-GCG System by RIA is a prescription-use diagnostic device designed for qualitative detection of human chorionic gonadotropin (hCG) in urine samples. It serves as a visual aid in clinical chemistry laboratories to confirm pregnancy by interpreting test strip results.

• How is the B-GCG System by RIA supplied, and is it sterile?

  The B-GCG System by RIA is supplied as a single-use, non-sterile diagnostic device. It includes multiple test strips referenced by various FEI numbers, intended for one-time use per test. Sterility is not applicable due to its non-sterile classification.

• Are there different models or sizes available for the B-GCG System by RIA?

  The B-GCG System by RIA features multiple test strip variants, each identified by unique FEI numbers (e.g., 3013332582, 3003102569). These variations may correspond to different lot codes or batch-specific configurations, but all function under the same regulatory framework for hCG detection.

• What are the storage requirements for the B-GCG System by RIA?

  The regulatory data for the B-GCG System by RIA does not specify detailed storage conditions. However, as a single-use, non-sterile diagnostic device, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures to preserve its integrity until use.

• Is the B-GCG System by RIA reusable, and does it require any special handling?

  No, the B-GCG System by RIA is explicitly designed for single-use only. Each test strip is intended for one-time use in detecting hCG in a urine sample. Reuse is not recommended, as it could compromise accuracy and reliability of the results.