# K980042: Careside Total Protein

- Pathway: 510(k) (Traditional)
- Applicant: Exigent Diagnostics, Inc.
- Decided: Feb 4, 1998 after 29 days
- Product code: CEK (Biuret (Colorimetric), Total Protein)
- Device class: 2
- Regulation: 21 CFR 862.1635
- 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 total protein from whole blood, heparinized plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

Source page: https://510kreport.com/device/K980042
Methodology: https://510kreport.com/methodology