Architect Total Bilirubin
by Abbott Laboratories 510(k)
Active
510(k) K121985
Overview
The ARCHITECT Total Bilirubin assay is a diagnostic device used for the quantitation of total bilirubin in human serum or plasma. It is designed for use on the ARCHITECT c8000 system and employs diazo colorimetry methodology to measure bilirubin, an organic compound produced during the breakdown of red blood cells, aiding in the diagnosis and treatment of conditions related to liver function and hemolysis.
The device is supplied as a reagent assay for in vitro diagnostic use and is intended for use in clinical laboratory settings. It is classified as a Class II medical device under FDA regulation number 862.1110 with product code CIG, and received FDA 510(k) clearance (K121985) on February 1, 2013, based on substantial equivalence to a legally marketed device. The assay is not described as sterile, single-use, reusable, or MRI-safe in the provided data, and no storage conditions are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121985 | Date1 Feb 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
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 Abbott Laboratories
Questions
What is the ARCHITECT Total Bilirubin assay used for?
The ARCHITECT Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma, aiding in the diagnosis and treatment of conditions related to liver function and hemolysis by measuring bilirubin, an organic compound produced during red blood cell breakdown.
How is the ARCHITECT Total Bilirubin assay supplied and what system is it designed for?
The assay is supplied as a reagent for in vitro diagnostic use and is specifically designed for use on the ARCHITECT c8000 system, employing diazo colorimetry methodology to measure bilirubin levels in clinical laboratory settings.
Is the ARCHITECT Total Bilirubin assay sterile, single-use, or reusable?
The provided data does not describe the ARCHITECT Total Bilirubin assay as sterile, single-use, or reusable; no information regarding sterility or reusability is included in the device specifications.