# K102481: Autosure Voice 3 Blood Glucose Monitoring System and Test Strip

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Apr 28, 2011 after 241 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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) AutoSure Voice II meter: named in the summary without a submission number
- (no number) AutoSure test strips: named in the summary without a submission number

## Indications for use
AutoSure Voice 3 Blood Glucose Monitoring System: The AutoSure Voice 3 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 lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. AutoSure Blood Glucose Test Strips: The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice 1I and AutoSure Voice 3 Blood Glucose Meters to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice 11 and AutoSure Voice 3 Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results. They are intended for self-testing by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Source page: https://510kreport.com/device/K102481
Methodology: https://510kreport.com/methodology