Olympus Total Bilirubin Reagent
by Olympus Corp. 510(k)
Active
510(k) K923609
Overview
A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. This reagent is used in diazo colorimetry for the quantitative determination of bilirubin in clinical specimens.
The device is supplied as a reagent for in vitro diagnostic use. It is classified as a Class II medical device under regulation number 862.1110, with product code CIG, and has received FDA 510(k) clearance (K923609) as substantially equivalent to a legally marketed device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923609 | Date2 Oct 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- Withdrawn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 Total Bilirubin Reagent used for?
The Olympus Total Bilirubin Reagent is intended for the quantitative determination of bilirubin (total or direct) in plasma or serum specimens using diazo colorimetry, aiding in the assessment of liver function and hemolytic conditions.
How is the Olympus Total Bilirubin Reagent supplied and what is its intended use?
The reagent is supplied as an in vitro diagnostic (IVD) reagent for use in clinical laboratories to measure bilirubin levels in blood specimens, and it is not intended for direct patient administration or in vivo use.
Is the Olympus Total Bilirubin Reagent sterile or single-use?
The reagent is not supplied sterile and is not classified as a single-use device; it is a consumable reagent intended for multiple uses within a test run until expiration, following manufacturer stability and handling guidelines.
What regulatory pathway was used for the Olympus Total Bilirubin Reagent?
The device received FDA 510(k) clearance (K923609) as substantially equivalent to a legally marketed predicate device, based on its intended use, technology (diazo colorimetry), and performance characteristics.