Description
multiCare-in
Glucose strips Page
Description
Quantitative whole blood glucose test. For self-monitoring.
SAMPLE: capillary blood. Minimum volume: 0.5 mcL.
HEMATOCRIT RANGE: 30-55%
MEASUREMENT RANGE: 10-600 mg/dL (0.6-33.3 mmol/L)
SENSITIVITY: minimum measurable value: 10 mg/dl
PERFORMANCE FEATURES
REPEATABILITY EVALUATION
The multiCare-in glucose strips showed good performance.
Based on the results, the CV is:
- for glucose concentrations < 100 mg/dL, from 2.4% to 4.3%
- for glucose concentrations ~ 100 mg/dL, 2.0% to 2.8%
EVALUATION OF REPRODUCIBILITY (INTERMEDIATE PRECISION)
The multiCare-in glucose strips showed good performance in all ranges.
Three lots were evaluated, below are the CVs obtained:
Lot. 1: CV between 2.53% and 4.72%
Lot. 2: CV between 2.66% and 4.29%
Lot. 3: CV between 3.03% and 4.29%
1. ACCURACY
Comparison of the multiCare-in blood glucose monitoring system with the reference method using simultaneously collected capillary whole blood samples from 100 subjects.
1.1 Acceptability criteria
Minimum acceptable requirements for accuracy according to ISO 15197:2015.
- 95% of individual blood glucose results must fall within ± 15 mg/dL (0.83 mmoi/L) for glucose concentrations < 100 mg/dL (5.55 mmol/L).
- 95% of individual blood glucose results must fall within ± 15% for glucose concentrations ≥ 100 mg/dL (5.55 mmol/L)
1.2 Results
System Accuracy Results for Glucose Concentrations < 100 mg/dL (5.55 mmol/L)
System Accuracy Results for Glucose Concentrations ≥ 100 mg/dL (5.55 mmol/L)
System accuracy results for glucose concentrations between 28 mg/dL (1.5 mmol/L) and 580 mg/dL (32.2 mmol/L)
within ± 15 mg/dL (0.83 mmol/L) or within ± 15% = 590/600 (98.3%) READING TIME: 5 seconds
TEMPERATURE OF USE OF THE STRIPS: 10-40°C
Components
Glucose Oxidase: 21 mcg; Mediator (Hexaammineruthenium chloride): 139 mcg; Buffer5.7 mcg; Stabilizer: 86 mcg.
Warnings
To be used with the instrument.
Conservation
Store at a temperature between 4° and 30°C.
EXPIRY AFTER OPENING: 90 days
EXPIRY: 24 months
Format
Contains: strips; 1 leaflet; 1 data chip.
Available packs of 10, 25 and 50 strips
Cod.
3830220 (10 strips)
3830230 (25 strips)
3830280 (50 strips)
Quantitative whole blood glucose test. For self-monitoring.
SAMPLE: capillary blood. Minimum volume: 0.5 mcL.
HEMATOCRIT RANGE: 30-55%
MEASUREMENT RANGE: 10-600 mg/dL (0.6-33.3 mmol/L)
SENSITIVITY: minimum measurable value: 10 mg/dl
PERFORMANCE FEATURES
REPEATABILITY EVALUATION
The multiCare-in glucose strips showed good performance.
Based on the results, the CV is:
- for glucose concentrations < 100 mg/dL, from 2.4% to 4.3%
- for glucose concentrations ~ 100 mg/dL, 2.0% to 2.8%
EVALUATION OF REPRODUCIBILITY (INTERMEDIATE PRECISION)
The multiCare-in glucose strips showed good performance in all ranges.
Three lots were evaluated, below are the CVs obtained:
Lot. 1: CV between 2.53% and 4.72%
Lot. 2: CV between 2.66% and 4.29%
Lot. 3: CV between 3.03% and 4.29%
1. ACCURACY
Comparison of the multiCare-in blood glucose monitoring system with the reference method using simultaneously collected capillary whole blood samples from 100 subjects.
1.1 Acceptability criteria
Minimum acceptable requirements for accuracy according to ISO 15197:2015.
- 95% of individual blood glucose results must fall within ± 15 mg/dL (0.83 mmoi/L) for glucose concentrations < 100 mg/dL (5.55 mmol/L).
- 95% of individual blood glucose results must fall within ± 15% for glucose concentrations ≥ 100 mg/dL (5.55 mmol/L)
1.2 Results
System Accuracy Results for Glucose Concentrations < 100 mg/dL (5.55 mmol/L)
| within ± 5 mg/dl (0.28 mmol/L) | within ± 10 mg/dl (0.56 mmol/L) | within ± 15 mg/dl (0.83 mmol/L) |
| 80/150 (53.3%) | 125/150 (86.6%) | 145/150 (96.6%) |
System Accuracy Results for Glucose Concentrations ≥ 100 mg/dL (5.55 mmol/L)
| within ± 5% | within ± 10% | within ± 15% |
| 274/450 (60.8%) | 411/450 (91.3%) | 445/450 (98.8%) |
System accuracy results for glucose concentrations between 28 mg/dL (1.5 mmol/L) and 580 mg/dL (32.2 mmol/L)
within ± 15 mg/dL (0.83 mmol/L) or within ± 15% = 590/600 (98.3%) READING TIME: 5 seconds
TEMPERATURE OF USE OF THE STRIPS: 10-40°C
Components
Glucose Oxidase: 21 mcg; Mediator (Hexaammineruthenium chloride): 139 mcg; Buffer5.7 mcg; Stabilizer: 86 mcg.
Warnings
To be used with the instrument.
Conservation
Store at a temperature between 4° and 30°C.
EXPIRY AFTER OPENING: 90 days
EXPIRY: 24 months
Format
Contains: strips; 1 leaflet; 1 data chip.
Available packs of 10, 25 and 50 strips
Cod.
3830220 (10 strips)
3830230 (25 strips)
3830280 (50 strips)
