# K163078: DC-Uibc-Cal

- Pathway: 510(k) (Abbreviated)
- Applicant: Sekisui Diagnostics P.E.I., Inc.
- Decided: Dec 8, 2016 after 35 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K925877 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925877: DC-Uibc-Cal, Diagnostic Chemicals, Ltd. (Usa) (1993) Summary page 4.

## Indications for use
For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.

Source page: https://510kreport.com/device/K163078
Methodology: https://510kreport.com/methodology