(260 days)
GlucoDr.S Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. 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.
GlucoDr.S Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoDr.S Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S Blood Glucose Test Strips are for use with GlucoDr.S Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
GlucoDr.S BLE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S BLE 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.
GlucoDr.S BLE Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. GlucoDr.S BLE Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S BLE Blood Glucose Test Strips are for use with GlucoDr.S BLE Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
GlucoDr.S NFC Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip. GlucoDr.S 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.
GlucoDr.S NFC Blood Glucose Monitoring System should not be used for the diagnosis of or diabetes. GlucoDr.S NFC Blood Glucose Monitoring System is not for use in neonates.
GlucoDr.S NFC Blood Glucose Test Strips are for use with GlucoDr.S NFC Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The subject systems are to measure and display glucose test results. The subject meters are portable devices using a battery with capability to store 500 test results in memory, and can search the stored test results with 7, 14, 30, 60, or 90-day average value of test results. This system provides beep, hypo/hyper warning limit, date/time setting, average period, and test reminder alarms settings.
The three systems which are GlucoDr.STM, GlucoDr.STM BLE, and GlucoDr.STM NFC are exactly the same devices except the data transfer features. The GlucoDr.S™ can transfer test results to a PC or to a smart device via a USB cable only, and the GlucoDr.S™M BLE offers Bluetooth data transfer features in addition to the USB cable port. The GlucoDr.S™ NFC offers NFC data transfer features in addition to the USB cable port.
The provided text describes the performance data for the GlucoDr.S Blood Glucose Monitoring System, including acceptance criteria and study results.
Here's the breakdown as requested:
1. A table of acceptance criteria and the reported device performance
The document provides performance data primarily for Precision Evaluation and Linearity Evaluation.
Precision Evaluation Study (Measured mg/dL)
| Samples | Acceptance Criteria (Pooled STD or CV) | Reported Pooled STD (mg/dL) | Reported Pooled CV (%) |
|---|---|---|---|
| Repeatability | |||
| Level 1 (39.1 mg/dL) | STD |
§ 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.