# K090043: Autosure Voice Blood Glucose Monitoring System, Model AS90011F9

- Pathway: 510(k) (Special)
- Applicant: Apex BioTechnology Corp.
- Decided: Apr 9, 2009 after 92 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) GlucoSure Voice BGM System: named in the summary without a submission number

## Most influential descendants
- K091914: Omnis Health Embrace Glucose Control Solution (2009), 1 descendant of its own
- K133197: Fdi Level I and Level II Glucose Controls for the Embrace NO Code (2014), 0 descendants of its own

## Indications for use
AutoSure Voice Blood Glucose Monitoring System: The AutoSure Voice 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. AutoSure Voice Test Strips: The AutoSure Voice Blood Glucose Test Strips are to be used with the AutoSure Voice Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice System is plasma-calibrated for easy comparison to lab result. The AutoSure Voice Blood Glucose Monitoring System is intended for self-testing by 1ersons 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/K090043
Methodology: https://510kreport.com/methodology