# K020232: Hypoguard Advance Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Hypoguard USA, Inc.
- Decided: Feb 12, 2002 after 29 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- 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 no predicate by number.

## Recalls of this device
- Nov 26, 2003 · Not classified · Z-0276-04: When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
- Nov 26, 2003 · Not classified · Z-0275-04: When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.

## 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 use with Hypoguard ADVANCE™ Blood Glucose Test Strips 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 Strips: The Hypoguard ADVANCE™ Blood Glucose Test Strips are intended for use with Hypoguard ADVANCE™ Blood Glucose Meter 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/K020232
Methodology: https://510kreport.com/methodology