Product Description

Blood Glucose Test Strips

• For blood glucose test, NO callibration is needed.
• High level of accuracy which has surpassed the standards of the New ISO15197:2013
• Tiny sample size - 0.5 μL of blood
• Quick results - 5 Seconds
• 0 ~ 70% Hematocrit Range
• Vial pack with 24 months of shelf-life

Advantages of our Test Strips

• Advanced Superior Sip-in (ASSI) Technology is available on all test strips
• High precision made with gold
• High quality with a long shelf life
• CV < 5%
• HCT Range 0%~70%
• Much greater level of accuracy with GDH-FAD Enyzme

Accuracy & Precision

The FORA 6 blood glucose monitoring sytem fulfills the ISO 15197 criteria.

According to test results, the CVs of repeatability were 2.74% and 2.48% for venous and capillary samples, respectively. 100% of the measured glucose values from venous and capillary (fingertip) blood samples fell within either ±15 mg/dL (0.83mmol/L) of the average comparison measurement result at glucose concentration <100 mg/dL (5.55 mmol/L) or within ± 15% at glucose concentration >100 mg/dL (5.55 mmol/L).

Fig - The test result shows that the FORA 6® Series fulfills the standards of the CLSI & ISO 15197 criteria.

White Paper

Objective

The goal of the study was to assess the accuracy and reliability of seven blood glucose monitoring systems (BGMS) in clinical studies in accordance with the “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use Guidance for Industry and Food and Drug Administration Staff” criteria and more stringent guidelines.

Methods

The study sample was collected from 353 subjects. The capillary blood specimens were collected via fingertip stick used on participants from the AMCRI Institute (625 West Citracado Parkway, Suite 112, Escondido, CA 92025) and tested on three different lots of test strips.The study sample was collected from 372 subjects. The venous blood specimens were collected from participants at the AMCRI Institute (625 West Citracado Parkway, Suite 112, Escondido, CA 92025) and tested on three different lots of test strips.

Results

The FORA® GoldAdvance Plus(FORA® 6 Connect)*BGMS has met the requirements of the “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use Guidance for Industry and Food and Drug Administration Staff” from all three lots of test strips tested.

Fig-1. Consensus Error Grid for FORA GoldAdvance Plus (FORA 6 Connect) with three reagent system lots (Capillary Blood)

Fig-2. Consensus Error Grid for FORA GoldAdvance Plus (FORA 6 Connect) with three reagent system lots (Venous Blood)

ConclusionThis study showed that when compared with the test results with a laboratory reference, the FORA®GoldAdvance Plus(FORA® 6 Connect) blood glucose monitoring system met the current accuracy standard in accordance with the “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use Guidance for Industry and Food and Drug Administration Staff”.

Package Content

• 25 Glucose test Strip