# K122307: Diavue Prudential Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Biocare Corporation
- Decided: Apr 5, 2013 after 247 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 K082482 (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)
- K082482: Fora TD-4251/U-Right TD-4252/U-Right TD-4254 Blood Glucose Monitoring System, Model TD-4251/TD-4252A/TD-4252B/TD-4254, Taidoc Technology Corporation (2009) Summary page 2.
- K093724: Fora Control Solution, Taidoc Control Solution, Taidoc Technology Corporation (2010) Summary page 2.

## Indications for use
The DIAVUE Prudential Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from finger). This system is intended to be used by a single person and should not be shared. It should not be used for the diagnosis of or screening for diabetes, or testing on neonates. The DIAVUE Blood Glucose Test Strips are to be used with the DIAVUE Prudential Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip. It is for use outside of body (in vitro diagnostic use). It is intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. The DIAVUE Control Solutions are used with the DIAVUE Prudential Blood Glucose Meter and DIAVUE Blood Glucose Test Strips to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.

Source page: https://510kreport.com/device/K122307
Methodology: https://510kreport.com/methodology