(187 days)
The GluNEO™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The GluNEO™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The GluNEO™ Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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).
The GluNEO™ Test Strips are for use with the GluNEO™ Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The GluNEO™ Control Solutions are for use with the GluNEO™ Meter and GluNEO™ Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
The GlucoDiary is a PC-based software intended for use in home to help people with diabetes in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Blood Glucose Monitoring System.
The GluNEO™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Professional 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 GluNEO™ Professional 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).
The GluNEO™ Professional Test Strips are for use with the GluNEO™ Professional Meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm. forearm, calf and/or thigh.
The GluNEO™ Professional Control Solutions are for use with the GluNEO™ Professional Meter and GluNEO™ Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GlucoDiary is a PC-based software intended for use in professional settings to help healthcare professionals in the review, analysis and evaluation of their patients' glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEOTM Professional Blood Glucose Monitoring System.
The GluNEOTM Blood Glucose Monitoring System consists of a meter, test strips and control solutions (level 1, level 2 and level 3), a lancing device and sterile lancets. With GluNEO™ Professional Blood Glucose Monitoring System, only auto-disabling or single use lancing device must be used.
This blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
The manufacturer carried out performance tests for the GluNEOTM / GluNEOTM Professional Blood Glucose Monitoring System in accordance with ISO 15197:2003.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state the quantitative acceptance criteria for each performance evaluation. It only states that the device "passed all of the tests based on pre-determined Pass/Fail criteria." Therefore, the table below will reflect the type of study conducted and the general conclusion.
| Acceptance Criteria Category | Reported Device Performance (as per ISO 15197:2003) |
|---|---|
| Method Comparison | Passed pre-determined Pass/Fail criteria |
| Matrix Comparison | Passed pre-determined Pass/Fail criteria |
| User Performance | Passed pre-determined Pass/Fail criteria |
| Alternative-site blood glucose measurement | Passed pre-determined Pass/Fail criteria |
| Non-clinical performance (functionality, reliability) | Passed pre-determined Pass/Fail criteria |
| Disinfectant efficacy & long-term impact on device | Complete inactivation of live virus; no change in performance or external materials after 10,980 cleaning/disinfection cycles. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the clinical evaluation (method comparison, matrix comparison, user performance, and alternative-site blood glucose measurement).
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set.
4. Adjudication Method:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the context of a blood glucose monitoring system, the ground truth would typically be established by a reference laboratory method rather than human expert adjudication of images or clinical assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is more typical for imaging devices where human interpretation plays a significant role. The GluNEOTM system is an in-vitro diagnostic device for quantitative measurement of glucose.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):
The performance data described focuses on the overall performance of the "GluNEOTM / GluNEOTM Professional Blood Glucose Monitoring System," which includes the meter and test strips. This essentially represents the "standalone" or "algorithm only" performance for a device of this nature, as the meter provides a direct quantitative reading without human interpretation of the measurement itself. The user performance study would evaluate how well users operate the system to obtain these readings.
7. Type of Ground Truth Used:
The ground truth for blood glucose monitoring systems is typically established by comparing the device's readings against a laboratory reference method (e.g., a glucose oxidase or hexokinase method performed on a clinical chemistry analyzer). While not explicitly stated, the mention of "method comparison" strongly implies this type of ground truth was used.
8. Sample Size for the Training Set:
The document does not specify a training set size. For in-vitro diagnostic devices like blood glucose meters, the development and calibration process would involve internal data, but specific "training set" sizes in the AI/machine learning sense are not typically reported in 510(k) summaries unless the device incorporates complex adaptive algorithms.
9. How the Ground Truth for the Training Set Was Established:
The document does not specify how the ground truth for any potential training set was established. As mentioned above, for a blood glucose meter, ground truth for calibration and internal development would be based on comparison to highly accurate laboratory reference methods.
§ 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.