Olympus Total Protein Reagent
by Olympus Corp. 510(k)
Active
510(k) K924659
Overview
The Olympus Total Protein Reagent is a biuret-based colorimetric reagent used for the quantitative measurement of total protein in serum, plasma, or urine samples. It operates by reacting with peptide bonds in proteins to produce a colored complex, enabling spectrophotometric analysis of protein concentration in clinical chemistry applications.
This reagent is supplied as a liquid for in vitro diagnostic use and is intended for single-use in automated or manual clinical chemistry analyzers. It is classified under product code CEK and has received FDA 510(k) clearance as substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided, and storage conditions are not detailed in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924659 | Date29 Dec 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- Withdrawn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
- Full name
- Olyumpus Total Protein Reagent
- 510(k) Number
- FDA Product Code
- CEK
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1635
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Olympus Corp.
Questions
What clinical chemistry applications is the Olympus Total Protein Reagent designed for, and how does it work?
The Olympus Total Protein Reagent is designed for quantitative measurement of total protein levels in serum, plasma, or urine samples using a biuret-based colorimetric method. It reacts with peptide bonds in proteins to generate a colored complex, which can then be analyzed spectrophotometrically to determine protein concentration. This makes it suitable for routine clinical chemistry testing in laboratories.
Is this reagent intended for use in automated or manual systems, and how is it supplied?
The Olympus Total Protein Reagent is supplied as a liquid and is intended for single-use in either automated or manual clinical chemistry analyzers. It is not designed for reuse, ensuring consistency and accuracy in protein measurement per batch.
Are there any specific storage instructions or sterility guarantees provided for this reagent?
The available data does not include specific storage conditions or sterility guarantees for the Olympus Total Protein Reagent. Users should refer to the manufacturer’s instructions for proper handling and storage to maintain reagent integrity.
What regulatory pathway was followed for FDA clearance, and what does this mean for clinical use?
The Olympus Total Protein Reagent received FDA 510(k) clearance under the Traditional Review pathway, classified as substantially equivalent to a predicate device. This means it was evaluated by the FDA’s Clinical Chemistry (CH) Advisory Committee and determined to meet safety and performance standards for its intended use in measuring total protein levels in clinical settings.