# K981183: Careside Glucose

- Pathway: 510(k) (Traditional)
- Applicant: Exigent Diagnostics, Inc.
- Decided: May 7, 1998 after 36 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 glucose from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and management of disorders of blood glucose regulation such as diabetes.

Source page: https://510kreport.com/device/K981183
Methodology: https://510kreport.com/methodology