Olympus Direct Bilirubin Reagent
by Olympus Corp. 510(k)
Active
510(k) K923608
Overview
The Olympus Direct Bilirubin Reagent is a diagnostic reagent used for diazo colorimetry to measure bilirubin levels in plasma or serum. Bilirubin is a yellow pigment produced during the breakdown of red blood cells, and its measurement is critical in assessing liver function, bile duct obstruction, and hemolytic disorders. This reagent facilitates quantitative analysis through a colorimetric reaction, enabling clinical laboratories to determine bilirubin concentrations accurately.
The reagent is supplied as a single-use diagnostic tool, intended for use in clinical chemistry settings. It is classified under product code CIG and has received FDA 510(k) clearance (K923608) as substantially equivalent to a predicate device. The device is regulated under 21 CFR 862.1110 and falls under Class II special controls. Storage conditions and handling instructions are specified in the manufacturer’s documentation, though no additional regulatory or sterility details are provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923608 | Date18 Aug 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- Withdrawn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
- CIG
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1110
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Olympus Corp.
Questions
What is the Olympus Direct Bilirubin Reagent used for?
The Olympus Direct Bilirubin Reagent is designed for diazo colorimetry, a method used to measure bilirubin levels in plasma or serum. Bilirubin is a key marker in diagnosing and monitoring liver function, bile duct obstructions, and hemolytic disorders. By enabling precise quantitative analysis through a colorimetric reaction, this reagent helps clinical laboratories accurately determine bilirubin concentrations for patient care.
How is the Olympus Direct Bilirubin Reagent supplied and intended for use?
This reagent is supplied as a single-use diagnostic tool, specifically intended for use in clinical chemistry settings. It is not reusable and must be discarded after one use to maintain accuracy and prevent cross-contamination. The reagent is part of a standardized workflow for bilirubin testing, ensuring consistency in laboratory results.
Is the Olympus Direct Bilirubin Reagent sterile?
The provided data does not specify whether the Olympus Direct Bilirubin Reagent is sterile. For clinical use, it is critical to follow the manufacturer’s instructions for handling and storage, which may include sterility requirements. Always verify sterility claims with the manufacturer’s documentation or safety data sheet.
What regulatory approval does the Olympus Direct Bilirubin Reagent hold?
The Olympus Direct Bilirubin Reagent has received FDA 510(k) clearance under the reference number K923608. This clearance indicates that the device is substantially equivalent to a predicate device and complies with FDA regulations under 21 CFR 862.1110. It is classified as a Class II device under special controls for clinical chemistry applications.
Are there different sizes or models of the Olympus Direct Bilirubin Reagent?
The available data does not specify multiple sizes or models for the Olympus Direct Bilirubin Reagent. It is listed as a singular product under the name provided, intended for general use in bilirubin measurement. For specific lot or variant details, refer to the manufacturer’s documentation or contact Olympus Corp. directly.