# K150396: Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Oct 14, 2015 after 238 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: 1 generation back to K102037 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102037: Autosure Voice II Blood Glucose Monitoring System and Test Strips, Apex BioTechnology Corp. (2010) Summary page 5.

## Indications for use
The AutoSure Voice Il 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. The meter includes voice functionality to assist visually impaired users. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring blood glucose levels in diabetes mellitus. This system is for single-patient use only and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended 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 Il Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Pro 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. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use. The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice I Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Source page: https://510kreport.com/device/K150396
Methodology: https://510kreport.com/methodology