# K060467: Prodigy Blood Glucose Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Devices, Inc.
- Decided: Jul 13, 2006 after 140 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.
17 later devices descend from it; 2 cite it directly.
0 of 19 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
- K073118: Prodigy Voice Blood Glucose Monitoring System (2008), 14 descendants of its own
- K091815: Supercheck 1 Blood Glucose Monitoring System, Model 6268 (2009), 6 descendants of its own
- K122338: Preferred Blood Glucose Monitoring System (2013), 3 descendants of its own
- K160038: UniStrip1 Generic Blood Glucose Test Strips (2016), 1 descendant of its own
- K141914: Prodigy Autocode Eject Blood Glucose Monitoring System (2015), 1 descendant 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 and palm. It is intended for use by healthcare professionals and 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 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/K060467
Methodology: https://510kreport.com/methodology