# K051115: Sentinel Iron Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Sentinel Ch. Srl
- Decided: Aug 25, 2005 after 115 days
- Product code: JIY (Photometric Method, Iron (Non-Heme))
- Device class: 1
- Regulation: 21 CFR 862.1410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871973 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972363: IL Test Iron, Instrumentation Laboratory CO (1997) Summary page 2.
- (no number) Roche UIBC: named in the summary without a submission number

## Indications for use
The Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Source page: https://510kreport.com/device/K051115
Methodology: https://510kreport.com/methodology