# K060325: Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Aug 16, 2006 after 188 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 K910593 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910593: Roche Reagent for Direct Bilirubin, Roche Diagnostic Systems, Inc. (1991) Summary page 2.
- K910591: Roche Reagent for Total Bilirubin, Roche Diagnostic Systems, Inc. (1991) Summary page 2.

## Most influential descendants
- K171401: ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 (2017), 0 descendants of its own
- K110780: Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech Clinical Systmes Elitrol I & II (2011), 0 descendants of its own

## Indications for use
ABX PENTRA Bilirubin, Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) for use on ABX PENTRA 400 Clinical Chemistry Analyzer. ABX PENTRA Bilirubin, Total CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma based on a photometric test using 2,4-dichloroaniline (DCA) and detergents for use on ABX PENTRA 400 Clinical Chemistry Analyzer. Measurements of the levels of bilirubin (direct or total), 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 block. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K060325
Methodology: https://510kreport.com/methodology