# K120649: Autosure Voice 3 Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Jul 6, 2012 after 126 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
Longest line of descent: 2 generations back to K102037 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113098: Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus Iii, Apex BioTechnology Corp. (2012)

## Indications for use
The AutoSure Voice 3 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearmh, or palm. 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 and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The AutoSure Plus Blood Glucose Test Strips are to be used with the AutoSure Voice 3 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Source page: https://510kreport.com/device/K120649
Methodology: https://510kreport.com/methodology