(687 days)
SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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 SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is intended to be used to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication.
SD GlucoNavii® Mentor NFC Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices.
The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor NFC Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is intended to transmit glucose values to compatible mobile application or PC software through use of radio frequency communication.
SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System is indicated for single-patient use at home (over-the-counter; OTC) and should not be shared, while The SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-the-counter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control. NFC devices contain near field communication (NFC) technology.
SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System includes:
- SD GlucoNavii® Mentor NFC Blood Glucose Meter
- SD GlucoNavii® Mentor NFC Blood Glucose Test Strips
- SD Glucose Check Strip
- SD Glucose Control Solution - Level M
- 3V Battery Type CR2032
- User Instruction Guide
- Quick Guide
- Test Strip Package Insert
- Control Solution Package Insert
- Carrying Case
- Lancing Device, Lancet
SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System includes:
- SD GlucoNavii® Mentor NFC Multi Blood Glucose Meter
- SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips
- SD Glucose Check Strip
- SD Glucose Control Solution Level M
- 3V Battery Type CR2032
- User Instruction Guide
- Quick Guide
- Test Strip Package Insert
- Control Solution Package Insert
- Carrying Case
Optional software accessory
- GlucoNavii® DMS
- GlucoNavii®
A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm. The system can also set the pre-meal and post-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format usually expected for complex medical imaging devices or AI-driven diagnostic tools. This submission is for a Blood Glucose Monitoring System, which falls under a different regulatory pathway.
However, based on the non-clinical and clinical tests performed, I can extract information related to "System Accuracy" and "User Performance Studies" as the closest equivalent to acceptance criteria and the studies performed.
Here's an analysis based on the provided text, structured to answer your questions as best as possible given the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "System accuracy evaluations (Method Comparison with Predicate Device) for the SD GlucoNavii Mentor NFC and NFC Multi Blood Glucose Monitoring Systems were performed according to ISO 15197." ISO 15197 is an international standard for in vitro diagnostic test systems for self-testing in managing diabetes mellitus. It defines minimum requirements for system accuracy.
While the exact numerical acceptance criteria from ISO 15197 are not explicitly listed in the document, it's a common standard for blood glucose meters. The document states that "The study results support that SD GlucoNavii® Mentor NFC and NFC Multi Blood Glucose Monitoring Systems are substantially equivalence to other predicate devices in the market" and that the testing "met all relevant standards requirements." This implies compliance with ISO 15197.
Based on typical ISO 15197:2013 (or earlier versions like 2003, which might have been relevant in 2015) standards for system accuracy:
| Acceptance Criteria (Typical ISO 15197) | Reported Device Performance (Implied) |
|---|---|
| **For glucose concentrations |
§ 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.