(193 days)
The GLUCOCARD™ 01 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 (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.
GLUCOCARD™ 01 Blood Glucose Meter:
The GLUCOCARD™ 01 Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD™ 01 Blood Glucose 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.
GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips:
GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the palm. GLUCOCARD™ 01 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.
CIECOCARD" 01 CONTROLA
For use with GLUCOCARD™ 01 Blood Glucose Meter and GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in three levels - Low (L), Normal (N) and High (H).
The GLUCOCARD 01 Blood Glucose Monitoring System consists of a meter, sensor test strips, and control solutions for use as an aid to monitor the effectiveness of diabetes control.
The ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples. The acceptance criteria and supporting study details are as follows:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in a table format that compares against device performance. However, it indicates "a full array of in-house and clinical testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems." The conclusion states that "bench testing results and clinical testing results support the Indications for Use and the claim of substantial equivalence to the predicate," the Advance Micro-draw BGM.
Based on typical FDA expectations for blood glucose monitoring systems, common accuracy criteria include:
- ISO 15197:2003 (older standard applicable around 2008):
- 95% of results must be within ±15 mg/dL of the laboratory 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.