# K024347: Express Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Hypoguard USA, Inc.
- Decided: Mar 28, 2003 after 88 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) Hypoguard AdvanceTM Blood Glucose Monitoring System: named in the summary without a submission number

## Indications for use
Express Blood Glucose Monitoring System: The Express Blood Glucose Monitoring System intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by health care professionals, as an aid to monitor the effectiveness of diabetes control. Express Control Solution: Express Control Solution is intended for use with the Express as a quality control check to verify the accuracy of blood glucose test results. Use the Express Control Solution to verify that the Express System is functioning properly.

Source page: https://510kreport.com/device/K024347
Methodology: https://510kreport.com/methodology