Olympus Creatinine Reagent
by Olympus Corp. 510(k)
Active
510(k) K931939
Overview
The Olympus Creatinine Reagent is a diagnostic reagent used for the colorimetric determination of creatinine in serum or plasma samples. It employs the alkaline picrate method, a standard biochemical assay for measuring creatinine levels, which is critical for assessing renal function and diagnosing conditions such as kidney disease.
This reagent is supplied as a liquid for in vitro diagnostic use in clinical chemistry laboratories. It is intended for single-use applications and requires no special handling beyond standard laboratory protocols. The device is classified under product code CGX and has received FDA 510(k) clearance, adhering to regulatory standards for Class II medical devices under special controls. Storage conditions and expiration dates are specified on the packaging.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931939 | Date21 Sep 1993 | 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- Withdrawn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
- CGX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1225
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Olympus Corp.
Questions
What is the Olympus Creatinine Reagent used for?
The Olympus Creatinine Reagent is designed for the colorimetric determination of creatinine in serum or plasma samples. Creatinine levels are a key biomarker for assessing renal function, helping diagnose and monitor conditions like kidney disease. The alkaline picrate method it employs is a standard biochemical assay widely used in clinical chemistry laboratories.
How is the Olympus Creatinine Reagent supplied, and is it reusable?
The reagent is supplied as a liquid for in vitro diagnostic use. It is intended for single-use applications only, meaning each vial or bottle is meant to be used once before disposal. This design ensures accuracy and prevents cross-contamination, adhering to standard laboratory protocols for diagnostic reagents.
Does the Olympus Creatinine Reagent require special handling or storage?
The reagent does not require special handling beyond standard laboratory protocols, but storage conditions and expiration dates are clearly marked on the packaging. It is essential to follow these instructions to maintain the reagent’s stability and accuracy. Improper storage could compromise test results, so always refer to the label for guidance.
Is the Olympus Creatinine Reagent sterile, and what regulatory approval does it have?
The Olympus Creatinine Reagent is intended for in vitro diagnostic use, but sterility is not explicitly mentioned in the provided data. However, as a reagent used in clinical chemistry, it is typically handled under aseptic conditions in a laboratory setting. The device has received FDA 510(k) clearance, confirming it meets regulatory standards for Class II medical devices under special controls.
What product code and advisory committee classification does the Olympus Creatinine Reagent fall under?
The Olympus Creatinine Reagent is classified under product code CGX and falls within the Clinical Chemistry advisory committee (CH) category. This classification reflects its use in biochemical assays for renal function assessment, aligning with the FDA’s regulatory framework for diagnostic reagents.