Glucose Oxidase Rate Reagent

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

510(k) Number

K811165 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Bun Rate Reagent

  Class II

  FDA 510(k) K811193 Active Cleared 10 Jul 1981

• Sodium/Potassium Reagent Kits

  Class II

  FDA 510(k) K811310 Active Cleared 10 Jul 1981

• Chemcard Glucose Test

  Class II

  FDA 510(k) K943503 Active Cleared 23 Jul 1996

• Chloride Reagent Kit

  Class II

  FDA 510(k) K811319 Active Cleared 13 Aug 1981

• Astra

  Class II

  FDA 510(k) K811381 Active Cleared 13 Aug 1981

• Solid Phase Deter Serum Cholesterol Fr Whole Blood

  Class I

  FDA 510(k) K864159 Active Cleared 10 Jun 1988

See all devices from Chem-Elec, Inc. →

• What is the primary use of the Glucose Oxidase Rate Reagent in clinical settings?

  The Glucose Oxidase Rate Reagent is designed to measure glucose concentration in blood or urine by catalyzing the oxidation of glucose, producing hydrogen peroxide in a reaction proportional to glucose levels. This enables quantitative assessment of blood glucose, which is critical for monitoring diabetes and metabolic disorders in clinical chemistry laboratories.

• How is the Glucose Oxidase Rate Reagent supplied, and is it intended for single-use?

  The reagent is supplied as either a liquid or a powder that requires reconstitution. It is explicitly intended for single-use in clinical chemistry laboratories, meaning each vial or packet is designed for one-time use only.

• Does this reagent require any special sterilization or handling beyond standard laboratory practices?

  No special sterilization is required beyond standard laboratory practices. The reagent is compatible with conventional laboratory equipment, and handling follows typical biochemical reagent protocols—no additional sterilization or special precautions are mentioned.

• What regulatory pathway was followed for FDA clearance of this device?

  The Glucose Oxidase Rate Reagent was cleared through the FDA’s 510(k) process, specifically under a *Traditional* clearance route. It was determined to be *Substantially Equivalent* to a predicate device and falls under Class II medical devices (regulation number 862.1345). The clearance number assigned is K811165, and it was reviewed by the Clinical Chemistry (CH) advisory committee.

• Are there any special storage conditions or compatibility concerns for this reagent?

  No special storage conditions (e.g., temperature or humidity controls) are specified for this reagent. It is compatible with standard laboratory equipment, and handling follows typical biochemical reagent protocols. There are no MRI safety concerns mentioned, as it is not a device that would interact with magnetic fields.