Product Description

Test Strips

Β-Ketone (KB)

• Designed for diabetics who prefer a self-testing option
• Enzyme: Hydroxybutyrate Dehydrogenase
• Tiny sample volume - 0.8 μL
• Quick result - 10 Seconds
• Measurement Ranges: 0.1~8.0 mmol/L
• Individual foil pack with 18 months of shelf-life

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

• 10 Cholesterol Strip