(36 days)
The EasyPlus mini R9N SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The EasyPlus mini R9N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R9N Blood Glucose Test Strips must be used with the EasyPlus mini R9N Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The EasyPlus mini R9N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. EasyPlus mini R9N Blood Glucose Test Strips must be used with the EasyPlus mini R9N Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
EasyPlus mini R9N Glucose Control Solutions: For use with the EasyPlus mini R9N meter and EasyPlus mini R9N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.
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Here's an analysis of the provided text, focusing on Acceptance Criteria and the Study that proves the device meets those criteria, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text (FDA 510(k) summary) does not explicitly state the acceptance criteria in a table format with corresponding reported device performance for a study. Instead, it refers to the device being substantially equivalent to legally marketed predicate devices. This implies that the device's performance is expected to be comparable to established devices in the market that have already met certain performance standards.
The indications for use describe the intended performance capabilities, but not specific numerical acceptance criteria. For example, it measures "quantitative measurement of glucose" and acts as "an aid to monitor the effectiveness of diabetes control."
To provide a hypothetical table based on typical glucose meter requirements, and assuming the device met these implicit standards for substantial equivalence:
| Performance Metric (Hypothetical) | Acceptance Criteria (Hypothetical, based on ISO 15197 or similar) | Reported Device Performance (Implied from Substantial Equivalence and typical device data in 510(k)s) |
|---|---|---|
| Accuracy (Against Lab Reference) | 95% of results within ±15 mg/dL or ±15% of reference 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.