Deskripsi Produk
Seri FORA 6 Plus adalah pengukur multi-parameter pertama di dunia dan hadir dalam tiga model: FORA® 6 Connect, FORA® 6 Plus, dan FORA® 6 Smart.
Untuk pengukuran glukosa darah, FORA® 6 series sederhana membutuhkan ukuran sampel yang sangat kecil (0,5 µL darah) dan waktu reaksi 5 detik.
Hasil tes yang andal dapat membantu pengguna mengelola kondisi kesehatan mereka sendiri atau pasien mereka dan membuat perubahan gaya hidup yang tepat waktu menghindari hipoglikemia atau hiperglikemia.
Highlights
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.
Conclusion
This 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”.
*Product has been registered with KEMENKES RI AKL Certification Numbers.KEMENKES RI AKL 20101913005
Our Official Store