(48 days)
For single use device: The TD-4257 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared. The TD-4257 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The TD-4257 Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
For multiple patient use device: The TD-4257 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4257 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 in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel. The system is only used with single-use, auto-disabling lancing devices. The TD-4257 Multi Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results.
The provided text does not contain specific acceptance criteria or detailed study results for the TD-4257 Blood Glucose Monitoring System.
Instead, it states that the TD-4257 system has the "same performance characteristics as the predicate device" (TD-4239) and that a "comparison of system accuracy performance demonstrated that the TD-4257... and the TD-4239... are substantially equivalent." It also mentions "Software verification and validation testing confirmed that the performance, safety and effectiveness... are equivalent to the predicate device."
Without the performance characteristics and study details of the predicate device (TD-4239), it is impossible to fully answer the request for acceptance criteria and specific study results for the TD-4257.
Therefore, the following information is based on the lack of detailed performance data in this document and an explanation of what should be present based on the request.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Example based on typical blood glucose meter standards, not found in provided text) | Reported Device Performance (Reference to predicate, no specific numerical values in provided text) |
|---|---|
| +/- 15 mg/dL or +/- 15% 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.