Expert in BGM & PoCT

Updated Nov 2016

 About VivaChek

VivaChek Laboratories
Wilmington, DE, USA

One of the best BGM original manufacturers

VivaChek Biotech
(Hangzhou), China MNC with global perspective

VivaChek Lifecare
Professional and innovative
Chennai, India
VivaChek
Diagnostic Singapore

We commit ourselves to becoming one of the leading manufacturers of

BGM and PoCT in the global market
BGM: blood glucose monitoring
PoCT: point of care
MNC: mulAnaAonal company
Milestones Oct 2016: BGM available in ~ 40
countries including Germany, UK,
Netherlands, Australia etc.
Dec 2015: VivaChek
Ino BGM China SFDA
cerAed
Sep 2015: PoCT
project initated.
May 2015: ISO 13485:2012 VivaChek Indian
cerAed. VivaChek Ino branch established
BGM CE and ISO
15197:2013 cerAed,
entering EU market

Sep 2014: Medical

Device Manufacture
Oct 2016:
License granted
Aug 2013: VivaChek VivaChek Ino BGM clinical
established study published on JDST
April 2016: VivaChek FAD
BGM (GDH-FAD enzyme)
VivaChek bluetooth BGM
CE and ISO 15197:2013
CE and ISO 15197:2015
cerAed
cerAed

July 2015: VivaChek Ino BGM

succeeded in clinical evaluaAon by
IDK Germany with brilliant results

July 2014: 1st patent granted

Management team & Quality system

15+ years R&D experience in BGM & PoCT 

~20 years management and QA experience in top IVD 

companies 

Strict compliance with ISO 9001, ISO 13485, and the US 
FDAs QSR (Quality System Regulations) 
 Certificates

CE ISO 15197:2013 UK MHRA

Ireland FSC Australian RTGC UK NHS

Why select VivaChek BGM?

Expert in Glucose Meter

Focus on Glucose Meter

Dynamic: Quick reaction to the market

World-class: Technology, Facility and Management System

Why we are different? Professional, Innovative & Efficient

 VivaChek Cutting-edge technologies

HCT The system detects the Hematocrit

CorrecLon
signal of blood sample then reduces
The system detects the the interference within 10%
temperature signal then
compensates the effect
within 5%
Temperature
Auto-coding
CompensaLon

The system detects the coding

Accuracy info from each test strip
automatically

Unique formulation in the test

strip which is very stable under After detecting signals of various
Unique Unique
extreme conditions formulaLon Algorithm
common sources of interferences, the
meter runs unique algorithm and gives
highly accurate result
 VivaChek clinical performance
98.8% results within 15 mg/dL (0.83 mmol/L) or 15% -
study by IDK Germany for VivaChek Ino 

Accuracy

Hematocrit interference <10% with range:

20-70% with GOD
0-70% with GDH-FAD

CV < 3% 

Precision Stability
Testing Temperature: 5-45C
Test strips @65C for 2 weeks: variation
<5%
Strip Shelf life 24 months
Auto-coding
Open shelf life 6 months 
Only 0.5uL blood
Test strip ejector
Easy-to-use
Lancet ejector
 Products development plan

TradiAonal BGM InfecAous diseases

technology new query technology new query

compression compression

processing processing
HbA1c Cardiac FerAlity

Diabetes Care Wireless BGM PoCT Analyzer

Blood ketone, lipid CGMS Drug of abuse Tumor

prole etc

Source: GE Industrial Internet, Pushing the boundaries of Minds and Machines

CE marked products (till Oct 2016)

All above BGM are EN ISO 15197:2015 (equal to ISO 15197:2013) certified by TV Rheinland
Innovative 8 electrodes No coding Low interference Wide operation
from HCT* temperature

0.5uL blood, less pain Fast 5 seconds Insufficient sample Strip ejector
detection
Evaluation by IDK Germany
 Clinical paper

Accuracy Evaluation of a CE-Marked

Glucometer System for Self-Monitoring
of Blood Glucose With Three Reagent
Lots Following ISO 15197:2013J
Diabetes Sci
Technol 1932296816670401,first
published on October 4, 2016
 Comparison of specifications
OneTouch
AccuChek Contour TS, OneTouch
Ultra, Select, Freestyle VivaChek Most others
Performa Next, Plus Verio
SelectSimple

ISO 15197:2013 Yes Yes Yes No Yes Yes No

Auto-coding No Yes Yes No Yes Yes One-code

20-70%
Hematocrit range 10-65% 0-70% 20-60% 30-55% 15-65% 30-55%
0-70%

GOD, GDH-
Enzyme Mut-Q GDH GDH-FAD GDH-FAD GOD GDH-FAD GOD, GDH-FAD
FAD

Strip ejector No No No No No Yes No

New products in the coming 12 months

Bluetooth + GSM Talking + Bluetooth (opLonal) Touch screen + Bluetooth + GSM POCT hospital
Thanks!