(86 days)
DiaCheck Smart Blood Glucose Monitoring System: The DiaCheck Smart Blood Glucose Monitoring System is intended for the quantitative rno Blacmost of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Smart Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Smart Blood Glucose Test Strips: The DiaCheck Smart Blood Glucose Test Strips are for use with the DiaCheck Smart Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Glucose Control Solution: The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.
DiaCheck Superior Blood Glucose Monitoring System: The DiaCheck Superior Blood Glucose Monitoring System is intended for the rne Black our of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Superior Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Superior Blood Glucose Test Strip: The DiaCheck Superior Blood Glucose Test Strips are for use with the DiaCheck rne Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates. DiaCheck Glucose Control Solution: The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.
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Please note that the provided document is a 510(k) clearance letter from the FDA, not a full study report or clinical trial documentation. Therefore, much of the detailed information typically found in such reports (like sample sizes for specific training/test sets, expert qualifications, adjudication methods, or MRMC study results) is not present. This letter primarily focuses on the FDA's determination of substantial equivalence based on the submitted materials, rather than providing a detailed breakdown of the underlying studies.
However, I can extract the acceptance criteria and the reported performance as presented in this document, and infer what can be from the context.
Acceptance Criteria and Device Performance for Glucose Test System
The DiaCheck Smart Blood Glucose Monitoring System and DiaCheck Superior Blood Glucose Monitoring System are intended for quantitative measurement of glucose in fresh capillary whole blood samples from fingertips. Based on the provided FDA 510(k) clearance, the acceptability of the device is determined by its substantial equivalence to legally marketed predicate devices, implying that its performance meets the regulatory standards for accuracy and reliability established for such systems.
The specific acceptance criteria for blood glucose monitoring systems typically involve accuracy metrics compared to a laboratory reference method. While these exact criteria are not explicitly detailed in the FDA clearance letter, common standards (e.g., ISO 15197) for blood glucose meters require that for glucose concentrations ≥ 4.2 mmol/L (75 mg/dL), 95% of the measured values should fall within ±15% of the reference value, and 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.