c

cur a y Acc
Ac o

er

rd
EN ISO

Great

ing
to
15197:2015

Multi-Functional
Monitoring Systems
Handheld Blood Glucose & Multiparameter Meters
World’s First
6-parameter
Device

For Advanced Diabetes Management

FORA® 6 Series measures blood glucose (BG),
hematocrit concentration (HCT), hemoglobin (HB),
β-Ketone (KB), uric acid (UA) and total cholesterol (TCH),
in a simple, accurate and reliable way.
 World’s First
Multiparameter Handheld Devices 6-parameter
Device

with the level of precision and accuracy

according to laboratory analysis
The FORA® 6 series is the first handheld 6-parameter meter in the world that enables the measurements
of 6 parameters for a faster and more comprehensive testing. For blood glucose measurement, the FORA® 6
series simply requires a very small sample size (0.5 µL of blood) and a 5-second reaction time. The reliable
test results can help users manage their own or their patients' health conditions and make timely lifestyle
changes to avoid hypoglycemia or hyperglycemia.

Strip feed light

Connects wirelessly with
Bluetooth Smart technology,
which can easily be paired
with a smartphone / tablet
Strip ejection design
reduces the possibility of
cross-infection
White backlight, large display
and high contrast design.
3 meal tags : general (Gen), clear, easy to read
pre-meal (AC) and post-meal
(PC); 1 QC mode for control
solution test
Records your test results
1000 memory capacity and includes the time of
with date & time the measurement

1 x AAA battery Up , Down and Main

rubber buttons, easy to use
and clean

STRIP FEED 90 DAYS 1,000 PRE-MEAL / 4 ALARMS TELEHEALTH

LIGHT AVERAGE MEMORY SETS AFTER-MEAL CLOUD
Meters

Connect Plus

Multiparameters BG HCT HB KB TCH UA

Bluetooth Smart V4.0 All data can be exported via the strip port
embedded by FORA® My Dongle II

BLOOD GLUCOSE TEST STRIPS

• Tiny sample size - 0.5 µL of blood

• Quick results - 5 Seconds
• 0 ~ 70% Hematocrit Range
• Application: General Patients (Capillary;
Venous; Arterial); Dialysis Patients;
Gestational Diabetics; people with
cardiovascular diseases or metabolic
syndrome
• Neonatal Whole Blood; Alternative-site
testing

5s NO
0.5µl Coding

0.5µL SAMPLE 5 SECONDS GDH-FAD HIGH PRECISION AST (ALTERNATE ASSI NO CODING
VOLUME REACTION TIME ENZYME TEST STRIPS SITE TESTING) TECHNOLOGY
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%1
• HCT Range 0%~70%
• Much greater level of accuracy with
GDH-FAD Enzyme Sip-In
• 5-electrode Technology 1 2 3 4 5

1 Individual hematocrit level is

detected by touch
2
3
Blood sample is detected and measured
4
5 A detection point to avoid erroneous reading
due to insufficient blood sample volume
c
cur a y Acc
Ac o

er

rd
EN ISO
Great

ing
Accuracy & Precision

to
15197:2015

The FORA 6 blood glucose monitoring System Accuracy Plot

Capillary and Venous Whole Blood
sytem fulfills the ISO 15197 criteria2. 140

20%
120

According to test results, the CVs of 100

15%

repeatability were 2.74% and 2.48% for 80 12.5%

from laboratory analyzer results

10%

venous and capillary samples,

60
FORA Difference (mg/dL)

40

respectively. 100% of the measured 20

15
12

glucose values from venous and capillary

0
-12
-15
-20

(fingertip) blood samples fell within either -40

±15 mg/dL (0.83mmol/L) of the average

-10%
-60

-12.5%
-80

comparison measurement result at -100

-15%

glucose concentration <100 mg/dL (5.55 -120

Capillary Blood (n=960)
Venous blood (n=960)
CB Strip Lot 1
VB strip Lot 1
CB Strip Lot 2
VB strip Lot 2
CB Strip Lot 3
VB strip Lot 3
-20%

-140

mmol/L) or within ± 15% at glucose 0 100 200 300

Comparison method: Plasma results (mg/dL)

400 500 600

(Laboratory analyzers of YSI and Cobas)

concentration >100 mg/dL (5.55 mmol/L).

Fig - The test result shows that the FORA 6 ® Series fulfills the
standards of the CLSI3 & ISO 15197 criteria.
Reference:
1. Reliable approval and clinically validated by the AMCR institute (625 West Citracado Parkway, Suite 112, Escondido, CA 92025) in the US during the period
of the 15 th to the 22nd of April 2015. The reference measurements were performed according to the YSI 2300 STAT PLUS blood glucose analyzer.
2. ISO 15197:2013 & EN ISO 15197:2015 In Vitro Diagnostic Test Systems - Requirements for blood-glucose monitoring systems for self-testing in managing
diabetes mellitus.
3. Clinical and Laboratory Standards Institute (CLSI) 2013 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities.
Test Strips
BLOOD GLUCOSE (BG) β-KETONE (KB)
• For blood glucose test, NO callibration • Designed for diabetics who prefer a
is needed. self-testing option
• High level of accuracy which has • Enzyme: β-Hydroxybutyrate
surpassed the standards of ISO Dehydrogenase
15197:2015 • Tiny sample volume - 0.8µL
• Tiny sample size - 0.5µL of blood • Quick results - 10 Seconds
• Quick results - 5 Seconds • Measurement Ranges: 0.1~8.0mmol/L
• 0~70% Hematocrit Range • Individual foil pack with 18 months of
• Application: General Patients (Capillary; shelf-life
Venous; Arterial); Dialysis Patients;
Gestational Diabetics
• Neonatal Whole Blood; Alternative-site URIC ACID (UA)
testing
• Vial pack with 24 months of shelf-life • Designed for patients with diabetes or
gout who prefer a self-testing and
self-monitoring option.
BG-HCT-HB (3 IN 1) • Enzyme: Uric acid catalyst
• Tiny sample volume - 1.0µL
• 3 parameters in 1: Blood Glucose (BG), • Quick results - 15 Seconds
Hematocrit (HCT) & Hemoglobin (HB) • Measurement Ranges: 3~20mg/dL
• Enzyme: GDH-FAD • Individual foil pack with 18 months of
• Measurement Ranges: shelf-life
BG 10~600mg/dL
HCT 0~70%
HB 0~23.8g/dL TOTAL CHOLESTEROL (TCH)
• Sample volume - 0.5µL
• Quick results - 5 Seconds
• Designed for people with diabetes or
• Application: General Patients (Capillary;
cardiovascular diseases or metabolic
Venous; Arterial); Dialysis Patients;
syndrome who prefer a self-monitoring
Gestational Diabetics;
option.
• Neonatal Whole Blood; Alternative-site
• Enzyme: Cholesterol esterase /
testing
Cholesterol oxidase
• Individual foil pack with 18 months of
• Tiny sample volume - 3.0µL
shelf-life
• Quick results - 120 Seconds
• Measurement Ranges: 100~400mg/dL
• Individual foil pack with 18 months of
* All FORA® 6 meter kits include the FORA® 6 blood shelf-life
glucose test strips as standard. Other parameters
are available and can be purchased separately.

e l
T / HB β- k e t o n s Uric Ac s
id
holeste
ro
lucose BG / HC rip ip Tot al C trips
Blood G rips 3 in 1 Test St Tes t S t r
Test S
Test St ips
Test Str
System Accuracy Evaluation
FORA® 6 Connect versus Cobas Integra® 400 plus
System Accuracy: Section 6.3.3 Absolute differences between FORA 6 Connect and
ISO 15197:2013[1] / EN ISO 15197:2015[2] Cobas Integra® 400 plus
The system shall meet both of the following minimum criteria
120

100

FORA 6 Connect - Cobas Integra® 400 plus [mg/dl]

for acceptable system accuracy. 80

a) 95% of the measured glucose values shall fall within 60

40

either ± 0,83 mmol/l (± 15mg/dl) of the average measured 20

values of the reference measurement procedure at 0

-20

glucose concentrations < 5,55 mmol/l (<100 mg/dl) or -40

within ± 15% at glucose concentrations ≥ 5,55 mmol/l -60

-80

(≥100 mg/dl). -100

Lot_1
WG17H104-CEE
Lot_2
WG17H604-CEE
Lot_3

b) 99% of individual glucose measured values shall fall

WG17H904-CEE
-120
0 50 100 150 200 250 300 350 400 450 500 550
Glucose concentration (Cobas Integra® 400 plus) [mg/dl]
within zones A and B of the Consensus Error Grid (CEG)
for type 1 diabetes. Consensus Error Grid for FORA 6 Connect with
three reagent system lots
Introduction and Scope
The study was conducted by Institut für Diabetes-Technologie 550

Forschungs- und Entwicklungsgesellschaft mbH an der 500

E D C B A

Universität Ulm with Project No. IDT-1739(2)-FS[3] in between

A
30 November 2017 and 19 December 2017. The capillary 450

whole blood samples taken from 113 different subjects with

Blood glucose concentration (FORA 6 Connect) [mg/dl]

400

600 glucose values were obtained (200 from each of 3

reagent system lots). 350

B
300
Test Results
System accuracy result for glucose concentrations 250

< 100 mg/dL (5.55 mmol/L) 200

C
Reagent System Lot Within ±5 mg/dL Within ±10 mg/dL Within ±15 mg/dL
(Within ±0.28 mmol/L) (Within ±0.56 mmol/L) (Within ±0.83 mmol/L) 150

WG17H104-CEE 17 / 52 (32.7%) 35 / 52 (67.3%) 51 / 52 (98.1%) 100

D

WG17H604-CEE 23 / 52 (44.2%) 44 / 52 (84.6%) 52 / 52 (100%) 50

WG17H904-CEE 12 / 52 (23.1%) 36 / 52 (69.2%) 51 / 52 (98.1%) 0

0 50 100 150 200 250 300 350 400 450 500 550
Blood glucose concentration (Cobas Integra® 400 plus) [mg/dl]

System accuracy result for glucose concentrations Region Number Percent WG17H104-CEE
≥ 100 mg/dL (5.55 mmol/L) A 598 99.67 % WG17H604-CEE
B 2 0.33 % WG17H904-CEE

Reagent System Lot Within ±5% Within ±10% Within ±15% C 0 0.00 %
D 0 0.00 %
E 0 0.00 %
WG17H104-CEE 104 / 148 (70.3%) 137 / 148 (92.6%) 148 / 148 (100%) Due to rounding the sum of percentages may slightly differ from 100%.

WG17H604-CEE 100 / 148 (67.6%) 136 / 148 (91.9%) 146 / 148 (98.6%) Conclusion
This study shows that the FORA 6 Connect Multi-functional
WG17H904-CEE 103 / 148 (69.6%) 144 / 148 (97.3%) 148 / 148 (100%)
Monitoring System is in compliance with ISO 15197:2013 /
System accuracy result for glucose concentrations between EN ISO 15197:2015 when comparing the test results to a
40 mg/dL (2.22 mmol/L) and 456 mg/dL (25.3 mmol/L) laboratory reference. In addition, 100% of individual glucose
values measured fall within zones A and B of the Consensus
Reagent System Lot
Within ±5mg/dL&±5% Within ±10mg/dL & ±10% Within ±15mg/dL & ±15%
(Within ±0.28 mmol/L & ± 5%) (Within ±0.56 mmol/L & ± 10%) (Within ±0.83mmol/L &± 15%)
Error Grid (CEG).

Reference
WG17H104-CEE 121 / 200 (60.5 %) 172 / 200 (86 %) 199 / 200 (99.5 %) 1. International Organization for Standardization. In vitro diagnostic test systems -- Requirements for blood-glucose
monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013.
2. International Organization for Standardization. In vitro diagnostic test systems -- Requirements for blood-glucose
WG17H604-CEE 123 / 200 (61.5 %) 136 / 148 (91.9%) 198 / 200 (99.0 %) monitoring systems for self-testing in managing diabetes mellitus. EN ISO 15197:2015.
3. Institut für Diabetes Technologie (2018, January 16). System accuracy evaluation of FORA 6 Connect
WG17H904-CEE 115 / 200 (57.5 %) 180 / 200 (90 %) 199 / 200 (99.5 %) Multi-functional Monitoring System based on ISO 15197:2013 & EN ISO 15197:2015. Project no.: IDT-1739(2)-FS
4. ForaCare Suisse AG. Clinical Validation List. www.foracare.ch/validations.html.
Connectivity
FOR PROFESSIONAL & HOME USE

ply.
Carrier 7:08 AM 100%

t Sim BG HCT HB KB TCH UA

Tes 2018 Health Data

Upload
State

Better.
02/10
6:59 BG 92

Live
02/09
23:35 HCT 42
02/09
23:35 BG 98
02/09
23:35 HB 14.2
02/09
23:30 TCH 160
02/09
23:25 UA 3.6
02/09
11:23 KB 0.4
02/08
18:42 BG 98
02/08
14:18 BG 101
02/08
6:17 BG 87

HM
Data Analysis FAQ Setting

iFORA HM

FORACARE TELEHEALTH SYSTEM

ForaCare not only offers various

medical devices and unique APPs for
patients, but also provides a telehealth
system for professional caregivers.

ForaCare Telehealth System can help

users consolidate their measurements.
Discover more:
www.foracare.ch/telehealth-solution
Specifications

Meters FORA® 6 Connect FORA® 6 Plus

Benefits
Multi-functional Monitoring Systems,
for Blood glucose, 3-in-1(BG/HCT/HB), β-Ketone, Uric Acid and Total Cholesterol testing

Measuring Range (BG test) 10 ~ 600mg/dL (0.55 ~ 33.3mmol/L)

Beep Sound Yes, ON / OFF / Universal Tone®

Ketone Warning Yes, if the value higher than 240mg/dL

Meal Tag AutoQC mode; GEN / AC / PC

LCD Backlight Yes

Strip Indication Light Yes

Strip Ejection Yes

Connectivity Bluetooth Smart V4.0 Strip Port Comm ( via FORA® My Dongle II)

Power Source 1 AAA battery

Battery life At least 1,000 times

Memory Capacity 1,000 memory sets

Dimension 89.8 (L) x 54.9 (W) x 18.0 (H) mm

Weight 64.1g (without Battery)

Operating Condition 8ºC (46.4ºF) ~ 45ºC (113ºF)

Test Strips *All FORA® 6 Test Strips Series can be purchased separately.
Model Blood Glucose BG-HCT-HB β-Ketone (KB) Uric Acid (UA) Total Cholesterol (TCH)
β-Hydroxybutyrate Cholesterol esterase
Enzyme Type GDH-FAD Dehydrogenase Uric Acid Catalyst Cholesterol oxidase

Blood Sample Requirement 0.5 µL 0.8 µL 1.0 µL 3.0 µL

Reaction Time 5 Seconds 10 Seconds 15 Seconds 120 Seconds

10 ~ 600 mg/dL BG : 10 ~ 600 mg/dL
Measurement Range (0.55 ~ 33.3mmol/L) HB : 0 ~ 23.8 g/dL 0.1 ~ 8.0 mmol/L 3 ~ 20 mg/dL 100 ~ 400 mg/dL

Haematocrit Range 0 ~ 70% 10 ~ 70% 20 ~ 60% 10 ~ 70%

Precision SD < 5 mg/dL (0.278 mmol/L) if < 100 mg/dL (5.55 mmol/L); ≦1 mmol/L, SD < 0.1mM;
CV < 7.5% CV < 7.5%
CV < 5% if ≧ 100 mg/dL (5.55 mmol/L) >1 mmol/L, CV < 7.5%

Accuracy ±15mg/dL if < 100mg/dl；±15% if ≧ 100mg/dL -- -- --

Alternative Site Testing Yes. (Fingertips, Palm, Upper arm or Forearm) Not Applicable Not Applicable Not Applicable

Applicable Sample Type Capillary; Venous Capillary; Venous Capillary; Venous Capillary; Venous
2ºC (35.6ºF) ~ 30ºC (86.0ºF) ; 2ºC (35.6ºF) ~ 30ºC (86.0ºF) ; 2ºC (35.6ºF) ~ 30ºC (86.0ºF) ;
Storage Condition 2ºC (35.6ºF) ~ 30ºC (86.0ºF) ; RH < 90% RH<85% RH<85% RH<85%

Strip Pack Vial / Individual Pack Vial / Individual Pack Vial / Individual Pack Vial / Individual Pack Vial / Individual Pack

Shelf Life Time 24M / 18M 18M 18M 18M 18M

ForaCare Suisse AG Distributor information

Neugasse 55, 9000 St. Gallen,
Switzerland
TEL : +41-71-220-1001
FAX : +41-71-220-1075
URL : www.foracare.ch
E-mail : chservice@foracare.com