# K053593: Prodigy

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Devices, Inc.
- Decided: Jul 6, 2006 after 195 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 K042005 (2004). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042005: Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222, Taidoc Technology Corporation (2004) Summary page 1.

## Most influential descendants
- K113077: Bioland G-423 Glood Glucose Monitoring System (2012), 2 descendants of its own
- K191657: Bioland Blood Glucose Monitoring System (2020), 1 descendant of its own
- K202739: Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System (2022), 0 descendants of its own

## Indications for use
The Prodigy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates. The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.

Source page: https://510kreport.com/device/K053593
Methodology: https://510kreport.com/methodology