# K152599: PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Ok Biotech Co., Ltd.
- Decided: Jul 20, 2016 after 313 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: 5 generations back to K042005 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141914: Prodigy Autocode Eject Blood Glucose Monitoring System, Ok Biotech Co., Ltd. (2015) Summary page 5.

## Indications for use
Prodigy® Astro 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® Astro Blood Glucose Monitoring System is intended to be used in the home by a single person and should not be shared. The Prodigy® Astro 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® Astro 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 Astro blood glucose meters to measure 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. Prodigy® Astro PRO 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® Astro PRO Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use by healthcare professionals in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The Prodigy® Astro PRO 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 PRO No Coding Test Strips are intended for use with the PRODIGY Astro PRO blood glucose meters to measure concentration of blood glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The system should only be used with single-use, auto-disabling lancing devices.

Source page: https://510kreport.com/device/K152599
Methodology: https://510kreport.com/methodology