(404 days)
The EG V1 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The system consists of the EG V1 Pro meter and the EG Pro Test Strips. The EG V1 Pro meter only is used with the EG Pro Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip.
EG Glucose Control Solution: For use with the EG V1 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EG V1 (BL) Self Monitoring Blood Glucose Test System is intended for the quantiatative measurement of glucose in fresh capillary whole blood from the fingertip, palm or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter[OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.
The system consists of the EG V1 (BL) meter and the EG V1 Test Strips. The EG V1 (BL) meter only is used with the EG V1 Test Strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from the fingertip, palm, or forearm.
EG Glucose Control Solution: For use with the EG V1 Pro Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The EG V1 Pro Self-Monitoring Blood Glucose System consists of the EG V1 Pro Blood Glucose Meter, EG Pro Glucose Test Strips, single-use Lancing Device and EG Level 2 Control Solution.
The EG V1 (BL) Self-Monitoring Blood Glucose System consists of the EG V1 (BL) Blood Glucose Meter, EG Glucose Test Strips, Auto-Lancet Device and EG Level 2 Control Solution.
Here's an analysis of the acceptance criteria and study details for the EG V1 Pro Self-Monitoring Glucose Test System and the EG V1 (BL) Self Monitoring Glucose Test System, based on the provided 510(k) Summary.
Key Observation: The document contains two separate 510(k) summaries for two devices:
- EG V1 Pro Self Monitoring Glucose Test System: Intended for professional use, measuring glucose in venous or capillary whole blood from the fingertip.
- EG V1 (BL) Self Monitoring Glucose Test System: Intended for Over-The-Counter (OTC) / home use, measuring glucose in capillary whole blood from fingertip, palm, or forearm.
Both summaries reference the same performance characteristics data, indicating that the underlying technology and analytical performance studies likely apply to both, with clinical accuracy studies differing based on professional vs. patient use and anatomical sites. I will present the acceptance criteria and study details as they apply to the respective devices and their specific accuracy studies.
EG V1 Pro Self Monitoring Glucose Test System (Professional Use)
1. Table of Acceptance Criteria and Reported Device Performance (Professional Use)
The acceptance criteria for system accuracy are based on ISO 15197:2003.
| Performance Metric | Acceptance Criteria (ISO 15197:2003) | Reported Device Performance (Professional Use) | Meets Criteria? |
|---|---|---|---|
| System Accuracy (Professional Use) | |||
| For 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.