# K102049: Clever Choice Voice+ Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Taidoc Technology Corporation
- Decided: May 27, 2011 after 310 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 K083664 (2009). 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)
- K100406: Fora V20 Blood Glucose Monitoring System, Taidoc Technology Corporation (2010) Summary page 2.

## Indications for use
The Clever Choice Voice + Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions. The Clever Choice Voice+ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Source page: https://510kreport.com/device/K102049
Methodology: https://510kreport.com/methodology