# K142785: PRODIGY iConnect Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ok Biotech Co., Ltd.
- Decided: Dec 17, 2015 after 447 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
The PRODIGY iConnect 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 iConnect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The PRODIGY iConnect 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 iConnect 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). PRODIGY No Coding Blood Glucose Test Strips are intended for use with the PRODIGY iConnect blood glucose meter to measure the concentration of 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 Blood Glucose Test Strips are used as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K142785
Methodology: https://510kreport.com/methodology