Description
Quantitative test for glucose in whole blood. 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 CHARACTERISTICS
REPEATABILITY ASSESSMENT
The multiCare glucose strips have shown 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, from 2.0% to 2.8%
REPRODUCIBILITY ASSESSMENT (INTERMEDIATE PRECISION)
The multiCare glucose strips have shown good performance across all ranges.
Three batches were evaluated, and the following CVs were 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 blood glucose monitoring system with the reference method using whole capillary blood samples taken simultaneously 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 mmol/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
Accuracy results of the system 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%)

Accuracy results of the system 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%)

Accuracy results of the system 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%) READ TIME: 5 seconds
STRIP USAGE TEMPERATURE: 10-40°C

Components
Glucose Oxidase: 21 mcg; Mediator (Hexaammineruthenium chloride): 139 mcg; Buffer 5.7 mcg; Stabilizer: 86 mcg.

Warnings
To be used with the device.

Storage
Store at a temperature between 4° and 30°C.
EXPIRATION AFTER OPENING: 90 days
EXPIRATION: 24 months

Format
Contains: strips; 1 instruction leaflet; 1 date chip.
Package of 25 strips

Code 3830230