Roche B-HCG RIA Urine Standard

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

Full name

Roche(R) B-Hcg Ria Urine Standard

510(k) Number

K820942 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cobas Reagent for Calcium

  Class II

  FDA 510(k) K823577 Active Cleared 7 Jan 1983

• Test, in-Vitro Diagnostic

  Not classified

  FDA 510(k) K760089 Active Cleared 20 Jul 1976

• Hcg Radioimmunoassay

  Class II

  FDA 510(k) K811116 Active Cleared 13 May 1981

• Cobas Creatinine Standards

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  FDA 510(k) K823572 Active Cleared 7 Jan 1983

• Sensi-Tex

  Class II

  FDA 510(k) K790267 Active Cleared 21 Mar 1979

• Abuscreen Radioimmunoassay - Amphetamine

  Class II

  FDA 510(k) K823212 Active Cleared 29 Nov 1982

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• What is the Roche B-HCG RIA Urine Standard used for?

  This standard is designed for laboratory use in radioimmunoassay (RIA) testing of urine samples. It serves as a reference material to ensure the accuracy and reliability of quantitative measurements of beta-human chorionic gonadotropin (hCG), a key biomarker for detecting pregnancy. It helps maintain precision in clinical chemistry settings where calibration of diagnostic tests is critical.

• How is the Roche B-HCG RIA Urine Standard supplied?

  The standard is supplied as a single-use reference material. It is intended exclusively for laboratory calibration and quality control purposes, not for direct patient administration or repeated use. Each unit is meant to be used once to maintain consistency in pregnancy testing assays.

• Is the Roche B-HCG RIA Urine Standard sterile?

  The regulatory data does not specify beyond standard laboratory handling procedures. While it is intended for use in controlled laboratory environments, users should follow standard aseptic practices to ensure sterility during preparation and testing.

• What regulatory pathway was followed for this device?

  The Roche B-HCG RIA Urine Standard was granted FDA 510(k) clearance under the Substantially Equivalent (SESE) determination in 1982. It falls under FDA regulation 862.1155 and was reviewed by the Clinical Chemistry (CH) advisory committee. The clearance confirms its compliance with U.S. regulatory standards for prescription-use diagnostic devices.

• Are there different models or sizes available for this standard?

  The regulatory data does not indicate multiple models or sizes for this specific standard. It is supplied as a singular reference material for beta-hCG calibration in urine samples, adhering to a single-use format. For variations, users should refer to the manufacturer’s catalog or technical documentation.