# K141914: Prodigy Autocode Eject Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ok Biotech Co., Ltd.
- Decided: Apr 15, 2015 after 274 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: 4 generations back to K042005 (2004). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122338: Preferred Blood Glucose Monitoring System, Prodigy Diabetes Care, LLC (2013) Summary page 4.

## Most influential descendants
- K152599: PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System (2016), 0 descendants of its own

## Indications for use
Prodigy® AutoCode® Eject Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The Prodigy® AutoCode® Eject Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Prodigy® AutoCode® Eject Blood 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® AutoCode® Eject Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes, or for neonatal use. The alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). PRODIGY® No Coding Test Strips are intended for use with the PRODIGY® AutoCode® Eject blood glucose meter to measure the concentration of the blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh for self-testing at home. They are for testing outside the body (in vitro diagnostic use only) . Do not use them for diagnosis of, or screening for diabetes or for testing on neonates. PRODIGY® No Coding Test Strips are used as an aid to monitor the effectiveness of diabetes control. This system contains a speaking function, but is not intended for use by the visually impaired.

Source page: https://510kreport.com/device/K141914
Methodology: https://510kreport.com/methodology