# K980041: Careside Albumin

- Pathway: 510(k) (Traditional)
- Applicant: Exigent Diagnostics, Inc.
- Decided: Feb 4, 1998 after 29 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- 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 K912844 (1991). 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to measure albumin from whole blood, plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of numerous diseases involving mainly the liver or kidneys.

Source page: https://510kreport.com/device/K980041
Methodology: https://510kreport.com/methodology