Olympus Glucose Reagent
by Olympus Corp. 510(k)
Active
510(k) K922232
Overview
The Olympus Glucose Reagent is a hexokinase-based reagent designed for the quantitative measurement of glucose in blood and other body fluids. It operates as part of a clinical chemistry test system, enabling accurate glucose level assessment in laboratory settings.
This reagent is supplied as a single-use, non-sterile chemical reagent intended for use in clinical laboratories. It is classified under FDA product code CFR and has received a 510(k) clearance for use in glucose quantification. Storage and handling follow standard laboratory protocols for chemical reagents, with no specific MRI safety considerations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922232 | Date16 Jul 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CFR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Olympus Corp.
Questions
What type of test system does the Olympus Glucose Reagent integrate with, and how is it used in a clinical setting?
The Olympus Glucose Reagent is designed for use within a clinical chemistry test system, specifically for the quantitative measurement of glucose in blood and other body fluids. It employs a hexokinase-based method to provide accurate glucose level assessments in laboratory settings. Clinicians rely on this reagent as part of their workflow to analyze patient samples for glucose quantification, ensuring precise diagnostic or monitoring results.
Is the Olympus Glucose Reagent intended for single-use or repeated use, and what are the sterility considerations?
The Olympus Glucose Reagent is explicitly supplied as a single-use, non-sterile chemical reagent. Since it is not sterile, it must be handled in accordance with standard laboratory protocols for chemical reagents to avoid contamination. Repeated use is not recommended or supported by the manufacturer.
How should the Olympus Glucose Reagent be stored, and are there any special handling instructions?
The Olympus Glucose Reagent follows standard laboratory storage protocols for chemical reagents, as no specific storage instructions are provided beyond general handling guidelines. It should be stored in a way that maintains its integrity—typically in a clean, dry environment away from direct light or extreme temperatures. Since it is non-sterile, contamination risks must be mitigated by adhering to laboratory hygiene practices.
What regulatory pathway was followed for the approval of the Olympus Glucose Reagent, and what does this mean for its use?
The Olympus Glucose Reagent received FDA 510(k) clearance, which means it was determined to be substantially equivalent to a legally marketed predicate device under the Clinical Chemistry advisory committee. This regulatory route confirms its compliance with FDA standards for glucose quantification reagents, ensuring its safety and performance for use in clinical laboratories as intended.
Are there any safety considerations for using the Olympus Glucose Reagent, particularly in relation to imaging or environmental exposure?
The Olympus Glucose Reagent does not have any MRI safety considerations listed, as it is a chemical reagent and not a medical device with magnetic properties. However, standard laboratory safety protocols should be followed when handling it, including proper ventilation and disposal to avoid chemical exposure risks. Since it is non-sterile, contamination control remains critical during use.