# K110780: Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech Clinical Systmes Elitrol I & II

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Oct 7, 2011 after 200 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: 3 generations back to K811832 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060325: Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P, Horiba Abx (2006) Summary page 4.
- K033501: Modification to Calibrator for Automatic Systems (Cfas), Roche Diagnostics Corp. (2003) Summary page 6.
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera, Roche Diagnostics Corp. (2004) Summary page 8.

## Indications for use
ELiTech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELiTech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage. ELiTech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELiTech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage. ELiTech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Selectra analyzers. ELiTech Clinical Systems ELITROL I & ELITROL 11 are multi-parametric control sera for in vitro diagnostic use in the quality control of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Selectra analyzers.

Source page: https://510kreport.com/device/K110780
Methodology: https://510kreport.com/methodology