# K031388: Modification to Hypoguard Advance Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Hypoguard USA, Inc.
- Decided: May 22, 2003 after 20 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 Advance Blood Glucose Monitoring System: named in the summary without a submission number

## Indications for use
Hypoguard Advance Blood Glucose Monitoring System: The Hypoguard Advance Blood Glucose Monitoring System is 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. Hypoguard Advance Blood Glucose Meter: The Hypoguard Advance Blood Glucose Meter is 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. Hypoguard Advance Blood Glucose Test Strip’s: The Hypoguard Advance Blood Glucose Meter is 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. Hypoguard Advance Control Solution: Hypoguard Advance Control Solution is intended for use with the Hypoguard Advance Meter and Hypoguard Advance Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K031388
Methodology: https://510kreport.com/methodology