# K041881: Advance Micro-Draw Blood Glucose Monitoring System, Model 411100

- Pathway: 510(k) (Traditional)
- Applicant: Hypoguard USA, Inc.
- Decided: Mar 25, 2005 after 256 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) LifeScan OneTouch® Ultra® Blood Glucose Monitoring System: named in the summary without a submission number

## Indications for use
The Advance Micro-drawTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. 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 healthcare professionals, as an aid to monitor the effectiveness of diabetes control. Advance Micro-drawTM Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Advance Micro-drawTM Test Strips must be used with the Advance Micro-drawTM Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. For use with Advance Micro-drawTM Blood Glucose Meter and Advance Micro-drawTM Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K041881
Methodology: https://510kreport.com/methodology