# K980055: Careside Globulin

- Pathway: 510(k) (Traditional)
- Applicant: Exigent Diagnostics, Inc.
- Decided: Jan 28, 1998 after 22 days
- Product code: JGE (Turbidimetric Method, Globulin)
- Device class: 1
- Regulation: 21 CFR 862.1330
- 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 calculate globulin and albumin/globulin ratio from albumin and globulin results generated on the CareSide Analyzer by professionals to aid in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

Source page: https://510kreport.com/device/K980055
Methodology: https://510kreport.com/methodology