# K122338: Preferred Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Prodigy Diabetes Care, LLC
- Decided: Nov 5, 2013 after 460 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: 3 generations back to K042005 (2004). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073118: Prodigy Voice Blood Glucose Monitoring System, Diagnostic Devices, Inc. (2008) Summary page 1.

## Most influential descendants
- K141914: Prodigy Autocode Eject Blood Glucose Monitoring System (2015), 1 descendant of its own
- K152599: PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System (2016), 0 descendants of its own
- K142785: PRODIGY iConnect Blood Glucose Monitoring System (2015), 0 descendants of its own

## Indications for use
The Prodigy Preferred Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillry whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The Prodigy Preferred Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Prodigy Preferred Blond 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 Prodigy Preferred Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady -state times (when glucose is not changing rapidly). The Prodigy No Coding Test Strips are for use with the Prodigy Preferred Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingentips, forearm, upper arm, palm, calf or thigh.

Source page: https://510kreport.com/device/K122338
Methodology: https://510kreport.com/methodology