# K102037: Autosure Voice II Blood Glucose Monitoring System and Test Strips

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Aug 13, 2010 after 25 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.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices 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) AutoSure Voice meter and test strips: named in the summary without a submission number

## Most influential descendants
- K113098: Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus Iii (2012), 5 descendants of its own
- K131750: Autosure HT Blood Glucose Monitoring System (2014), 3 descendants of its own
- K161299: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System (2016), 2 descendants of its own
- K110571: Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use (2011), 2 descendants of its own
- K120064: Test, Blood Glucose System (2012), 1 descendant of its own

## Indications for use
The AutoSure Voice II Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (in Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for self-testing by persons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

Source page: https://510kreport.com/device/K102037
Methodology: https://510kreport.com/methodology