# K091991: Easy RA D Bil Reagent Model 10212, Easy RA Glu-H Reagent Model 10200

- Pathway: 510(k) (Special)
- Applicant: Medica Corp.
- Decided: Sep 4, 2009 after 64 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
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.

## Indications for use
The EasyRA direct bilirubin reagent is intended for the quantitative determination of Direct Bilirubin (DBIL) in the human serum of adults, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K091991
Methodology: https://510kreport.com/methodology