multiCare-in
Glucose Strips Page

Description
Quantitative test for whole blood glucose. 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-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%
REPRODUCIBILITY ASSESSMENT (INTERMEDIATE PRECISION)
The multiCare-in glucose strips demonstrated good performance across all ranges.
Three batches were evaluated, the CVs obtained are presented below:
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. PRECISION
Comparison between the multiCare-in blood glucose monitoring system and the reference method, using capillary whole blood samples collected simultaneously from 100 subjects.
1.1 Acceptability criteria
Minimum acceptable requirements for accuracy according to ISO 15197:2015.
- 95% of individual blood glucose results should 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 should 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
TAPE USAGE TEMPERATURE: 10-40°C

components
Glucose oxidase: 21 mcg; Mediator (hexaammineruthenium chloride): 139 mcg; Buffer solution 5.7 mcg; Stabilizer: 86 mcg.

warnings
To be used with the instrument.

Conservation
Store at temperatures between 4° and 30°C.
EXPIRY AFTER OPENING: 90 days
EXPIRY: 24 months

Format
Contains: strips; 1 leaflet; 1 data chip.
Pack of 25 strips

Code 3830230