# K971145: Glucosite Test System

- Pathway: 510(k) (Traditional)
- Applicant: Gds Technology, LLC
- Decided: Sep 17, 1997 after 173 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) YSI 2300 STAT PLUS Analyzer: named in the summary without a submission number

## Indications for use
The GDS® GlucoSite® Test System is a device for in vitro diagnostic use only. The GDS® GlucoSite® Test Card is intended for the quantitative determination of glucose in whole blood. It is intended for use with the Stat-Site® Meter. Targeted population: Patients except neonates and children under the age of 6 months. Environment of Use: Physician’s Office or other Professional Point of Care Setting

Source page: https://510kreport.com/device/K971145
Methodology: https://510kreport.com/methodology