(313 days)
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 Prodig® 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 screeming 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 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.
The Prodigy Astro Blood Glucose Monitoring System and the Prodigy Astro PRO Blood Glucose Monitoring System are identical devices (hereafter both are called the System), but the latter is claimed to be used not only in the home by a single person but also in professional healthcare settings.
The System consists of a meter and Prodigy No Coding Test Strips (or Prodigy PRO No Coding Test Strips). The System utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The System is marketed as a meter only with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card. The System is also marketed as a meter kit with a carrying case, batteries, Owner's Manual, Quick Reference Guide, Logbook, and Warranty Card, Prodigy Lancing Device, Prodigy Lancets, Prodigy No Coding Test Strips, and Control Solution.
The Prodigy No Coding Test Strips utilizes the active enzyme, Glucose Oxidase, derived from Aspergillus niger.
Here's a breakdown of the acceptance criteria and study information for the PRODIGY Astro Blood Glucose Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents acceptance criteria within the study result descriptions. The table below consolidates this information.
| Test Category | Acceptance Criteria (from document) | Reported Device Performance |
|---|---|---|
| Robustness Evaluation | Individual bias of meter measurements 0.95. 100 % of bias or bias (%) within ±10 % or 10%. | Met: Correlation coefficient > 0.95 (reported as 0.9998 to 0.9999 for R² and r). 100% of bias or bias (%) of individual glucose results fell within ±10 % or 10%. |
| System Accuracy Evaluation | > 95% of test results within ±15 mg/dL at glucose |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.