# K051432: Spotchem II Total Bilirubin, Total Protein and Albumin Tests

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Jun 17, 2005 after 16 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. The FDA summary names no predicate by number.

## Indications for use
The SPOTCHEM II Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. The SPOTCHEM II Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders. The SPOTCHEM II Albumin test is intended to measure the albumin concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys.

Source page: https://510kreport.com/device/K051432
Methodology: https://510kreport.com/methodology