# K113098: Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus Iii

- Pathway: 510(k) (Traditional)
- Applicant: Apex BioTechnology Corp.
- Decided: Jan 17, 2012 after 90 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.
5 later devices descend from it; 2 cite it directly.
0 of 7 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 1.
- (no number) AutoSure test strip: named in the summary without a submission number
- (no number) Contrex Plus control solutions: named in the summary without a submission number

## Most influential descendants
- 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
- K222234: GlucoSure ADVANCE Link Blood Glucose Monitoring System (2022), 0 descendants of its own
- K182992: BGM014 Blood Glucose Monitoring System (2018), 0 descendants of its own
- K120649: Autosure Voice 3 Plus Blood Glucose Monitoring System (2012), 0 descendants of its own

## Indications for use
AutoSure Voice 11 Plus Blood Glucose Monitoring System: The AutoSure Voice II Plus 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 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. AutoSure Plus Blood Glucose Test Strips: The AutoSure Plus Blood Glucose Test Strips are to be used with the AutoSure Voice TI 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. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Source page: https://510kreport.com/device/K113098
Methodology: https://510kreport.com/methodology