# K981883: Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent, Catalog Number 1877844

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 7, 1998 after 39 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K790335 (1979). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790335: Hycel M, Hycel, Inc. (1979) Summary page 1.

## Indications for use
The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is intended for use for the quantitative determination of direct bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Source page: https://510kreport.com/device/K981883
Methodology: https://510kreport.com/methodology