Multicare In Glucose Blood Glucose Measurement Strips 25 Pieces

Quantitative test of glucose in whole blood. For self-testing.
SAMPLE: capillary blood. Minimum volume: 0.5 mcL.
HEMATOCRIT RANGE: 30-55%
MEASURING RANGE: 10-600 mg/dL (0.6-33.3 mmol/L)
SENSITIVITY: lowest measurable value: 10 mg/dl
PERFORMANCE CHARACTERISTICS
REPEATABILITY EVALUATION
The multiCare-in glucose strips have shown good performance.
Based on the results, the CV is:
- for glucose concentrations < 100 mg/dL, 2.4% to 4.3%
- for glucose concentrations ~ 100 mg/dL, 2.0% to 2.8%
REPRODUCIBILITY EVALUATION (INTERMEDIATE ACCURACY)
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 capillary whole blood samples drawn simultaneously from 100 subjects.
1.1 Acceptability criteria
Minimum acceptable requirements for the accuracy according to ISO 15197:2015.
- 95% of individual blood glucose results must be 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 be 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 Concentrations of glucose ≥ 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
USE TEMPERATURE OF THE STRIPS: 10-40°C

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

Warnings
To be used with the instrument.

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

Format
Contains: strips; 1 leaflet; 1 data chip.
Packs available in 10, 25 and 50 strips