Multicare Glucose Tests, 50 strips, Biochemical Systems

Quantitative whole blood glucose test.

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: Minimum measurable value: 10 mg/dL
• PERFORMANCE CHARACTERISTICS
• REPEATABILITY EVALUATION.

The multiCare-in glucose strips have demonstrated 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 ASSESSMENT (INTERMEDIATE PRECISION)

The multiCare-in glucose strips showed good performance in all ranges.

Three lots were evaluated, with the following CVs:

• 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%.

ACCURACY:

Comparison of the multiCare-in blood glucose monitoring system with the reference method using capillary whole blood samples collected simultaneously from 100 subjects.

1.1 Acceptability Criteria

Minimum acceptable accuracy requirements 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

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

STRIP TEMPERATURE: 10-40°C.

Ingredients:

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

Warnings:

For use with the meter.

Storage:

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

Presentation: 50 strips