# K040391: Total Bilirubin Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Jun 2, 2004 after 106 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 13, 2012 · Class II · Z-2586-2017: Decrease reactivity of R 1 component.
- Jul 29, 2009 · Not classified · Z-1014-2010: R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and would not pass the required quality control (calibration and quality control testing) before b
- Feb 2, 2009 · Not classified · Z-1202-2009: The product performance fails due to precipitation of the R2 component.

## Indications for use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of direct and total bilirubin in human serum. It is intended for in vitro diagnostic use only. Studies suggest that direct and total bilirubin measurements provide information to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice.

Source page: https://510kreport.com/device/K040391
Methodology: https://510kreport.com/methodology