# K120921: Clever Choice

- Pathway: 510(k) (Traditional)
- Applicant: Simple Diagnostics, Inc.
- Decided: Aug 21, 2012 after 147 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
Longest line of descent: 3 generations back to K024194 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101307: Blood Glucose Monitoring System, Models AG-6081 and AG-6951, Andon Medical Co., Ltd. (2011) Summary page 1.

## Indications for use
The Clever Choice Voice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice + S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice Voice+ S Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Clever Choice Voice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice Voice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ S meters and Clever Choice +S Test Strips. The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice Voice+ M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice Voice+ M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly). The Clever Choice +M Blood Glucose Test Strips are for use with the Clever Choice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice Voice+ M meters and Clever Choice +M Test Strips. Only auto-disabling, single use lancing devices may be used with this device. The Clever Choice+ S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice+ S Blood Glucose Monitoring System is to be used by a single person and should not be shared. The Clever Choice+ S Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Clever Choice+ S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Clever Choice +S Blood Glucose Test Strips are for use with the Clever Choice+ S Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only). by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ S meters and Clever Choice +S Test Strips. The Clever Choice Voice+ M Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf and thigh. The Clever Choice + M Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. The Clever Choice Voice+ M Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, upper arm, calf and thigh should be done only during steady - state times (when glucose is not changing rapidly). The Clever Choice Blood +M Glucose Test Strips are for use with the Clever Choice+ M Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf and thigh. The Clever Choice Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Clever Choice+ M meters and Clever Choice +MTest Strips. Only auto-disabling, single use lancing devices may be used with this device.

Source page: https://510kreport.com/device/K120921
Methodology: https://510kreport.com/methodology