(39 days)
The GLUCOCARD 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01-mini Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
The ReliOn Micro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The ReliOn Micro Plus Blood Glucose Test Strips are intended to be used with the ReliOn Micro Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.
The GLUCOCARD 01-mini Blood Glucose Monitoring System and ReliOn Micro Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.
This document describes the 510(k) premarket notification for the GLUCOCARD 01-mini Blood Glucose Monitoring System and the ReliOn Micro Blood Glucose Monitoring System, which are intended for quantitative measurement of glucose in fresh capillary whole blood samples.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state the quantitative acceptance criteria for system accuracy in a table format, nor does it provide detailed numerical results of the device's performance against such criteria. It generally states that a "clinical study was done with persons with diabetes to evaluate system accuracy."
However, glucose monitoring systems like this are typically evaluated against standards like ISO 15197 for accuracy. A common acceptance criterion for blood glucose meters, as per ISO 15197, often includes:
- 95% of results falling within ±15 mg/dL of the reference method 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.