ISO 15197:2013 / EN ISO 15197:2015 Clinical Validation Study List for Blood Glucose Monitoring System

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1 List No. STUDY TITLE DATE / PLACE SCIENTIST BRIEF RESULTS TYPE OF STUDY 01 Intermeiate measurement precision Jan 2018 The FORA 6 Connect fulfille the requirements of evaluation of FORA 6 Connect Multi-functional Monitoring base on ISO 15197:2013 / EN ISO IDT-1739(4)-A-FS the section of ISO 15197:2013 / EN ISO 15197: : Measurement repeatability Dec 2017 The FORA 6 Connect has met the system evaluation of FORA 6 Connect Multi-functional Monitoring base on ISO 15197:2013 / EN ISO IDT-1739(3)-A-FS measurement repeatability evaluation, all results base on the requirements of ISO 15197:2013 / EN ISO 15197: : accuracy evaluation of FORA 6 Connect Multi-functional Monitoring base on ISO 15197:2013 & EN Nov 2017 IDT-1739(2)-FS The FORA 6 Connect fulfille the requirements of the ISO 15197:2013 & EN ISO 15197:2015 (Aitional ata evaluation versus the laboratory ISO 15197:2015 analyzer of Cobas Integra 400 plus). 04 Accuracy Evaluation Mar 2017 The FORA GolAvance Plus (FORA 6 Connect) has of FORA GolAvance Plus* Bloo Glucose Monitoring POC met the new FDA stanar (ISO 15197:2013 & EN ISO 15197:2015) compare to the laboratory analyzer of YSI 2300 STAT PLUS TM. *The BGM of FORA GolAvance plus is calle the Rev Apr V8 Page 1 of 9

2 List FORA 6 Connect in European Market. 05 Interference Testing of FORA 6 Connect Oct 2016 The FORA 6 Connect fulfills the requirements of the Multi-functional Monitoring base on ISO 15197:2013 / EN ISO ISO 15197:2013 & EN ISO 15197: : Evaluation the Accuracy of FORA 6 Plus Jun 2015 Chang Gung Meical The results emonstrate that 100% of reaings Self-monitoring system using specimens Founation & met the accuracy equirements of the ISO from venous an capillary bloo 15197:2013 & EN ISO 15197: Accuracy Evaluation of FORA Apr 2015 The FORA GolAvance Plus (FORA 6 Connect) has GOLD** Bloo Glucose Monitoring met the ISO 15197:2013 guielines compare to the laboratory analyzer of YSI 2300 STAT PLUS TM. ** The BGM of FORA Gol is calle the FORA 6 Connect in European Market. 08 Certificate of Conformity for FORA Aug 2015 TÜV SÜD Prouct The BGMS fulfills the requirements of ISO Certificate Diamon PRIMA DM10 Bloo Glucose Service GmbH 15197:2013. of Monitoring (No ) Conformit y 09 Certificate of Conformity for FORA Aug 2015 TÜV SÜD Prouct The BGMS fulfills the requirements of ISO Certificate Diamon MINI DM30 Bloo Glucose Service GmbH 15197:2013. of Monitoring (No ) Conformit y Rev Apr V8 Page 2 of 9

3 List 10 Performance Evaluation an Aug 2015 Results from the clinical stuy with 100 subjects Report for FORA ADVANCED pro emonstrate that the FORA GD40g Bloo Glucose GD40g Bloo Glucose plus β-ketone plus β-ketone Monitoring provies a high Monitoring (CE certification level of accuracy over a wie range of hematocrit uner review by LNE-GMED) an hemoglobin values at all testing in this stuy. 11 Performance Evaluation an Jun 2015 This stuy showe that the GD40g β-ketone Report for FORA ADVANCED pro monitoring system exceee the minimum GD40 Bloo Glucose plus β-ketone acceptable accuracy stanar of β-ketone when Monitoring (CE certification compare the test results with a laboratory uner review by LNE-GMED) reference. 12 Performance Evaluation an May 2015 Report for FORA GOLD Avance 15197:2013. accuracy results are 99.0%, Bloo Glucose Monitoring 99.5% an 99.0% within ±15mg/L & ±15%. Results (CE certification uner review by LNE-GMED) 13 Performance Evaluation an May 2015 Report for FORA COMFORT pro 15197:2013. accuracy results are 98.5%, GD40 Bloo Glucose Monitoring 100.0% an 99.5% within ±15mg/L & ±15%. Results within Consensus Error Gri zones A an B is 100%. 14 Performance Evaluation an May 2015 Report for FORA GD20 Bloo 15197:2013. accuracy results are 98.5%, Rev Apr V8 Page 3 of 9

4 List Glucose Monitoring 99.0% an 98.0% within ±15mg/L & ±15%. Results 15 Performance Evaluation an May 2015 Report for FORA COMFORT basic 15197:2013. accuracy results are 97.0%, G20 Bloo Glucose Monitoring 95.5% an 98.0% within ±15mg/L & ±15%. Results 16 Performance Evaluation an Apr 2015 Report for FORA Diamon MINI 15197:2013. accuracy results are 97.0%, DM30b Bloo Glucose Monitoring (IDT-1451-FS) 96.5% an 98.0% within ±15mg/L & ±15%. Results 17 Performance Evaluation an Mar 2015 Centre e Biologie This meter is in agreement with all the acceptance Report for FORA ADVANCED pro France Su Centre criteria of the ANSM. GD40 Bloo Glucose Monitoring Hospitalier LYON SUD 18 Performance Evaluation an Mar 2015 Centre e Biologie This meter is in agreement with all the acceptance Report for FORA Diamon France Su Centre criteria of the ANSM. PRIMA DM10 Bloo Glucose Hospitalier LYON Monitoring SUD 19 Certificate of Conformity for FORA Dec 2014 TUV Rheinlan LGA The evice has been teste an was foun to be in Certificate COMFORT pro GD40a Bloo Glucose Proucts GmbH accorance with ISO 15197:2013, clause of Rev Apr V8 Page 4 of 9

5 List Monitoring (AK ) Conformit y 20 Statement Letter for FORA COMFORT Oct 2014 DEKRA Certification DEKRA Certification B.V. eclares that the following Statement basic G20 Bloo Glucose Monitoring The B.V. mentione proucts of FORACARE SUISSE AG fulfill Letter Netherlan s (Ref. BLM/14-530) the minimum system accuracy performance criteria accoring to EN ISO 15197:2013, section 6.3.3a. This eclaration is base on a review of which the result is reporte in letter RL Performance Evaluation an Oct 2014 Report for FORA COMFORT voice (Fora ) 15197:2013. accuracy results are 95.0%, V30 Bloo Glucose Monitoring 95.0% an 96.0% within ±15mg/L & ±15%. Results 22 Performance Evaluation an Oct 2014 Report for FORA Diamon MINI (Fora ) 15197:2013. accuracy results are 99.0%, DM30b Bloo Glucose Monitoring 99.5% an 97.0% within ±15mg/L & ±15%. Results 23 Performance Evaluation an Oct 2014 Report for FORA COMFORT pro (Fora ) 15197:2013. accuracy results are 98.5%, GD40a Bloo Glucose Monitoring 98.5% an 99.0% within ±15mg/L & ±15%. Results Rev Apr V8 Page 5 of 9

6 List 24 Performance Evaluation an May 2014 Report for FORA COMFORT pro 15197:2013. The system accuracy results are GD40a Bloo Glucose Monitoring (IDT-1404-FS) 96.0%, 96.0% an 96.5% within ±15mg/L & ±15%. Results within Consensus Error Gri zones A an B is 100%. 25 Performance Evaluation an Feb 2014 Peiatrics Report for FORA COMFORT pro epartment of 15197:2013. The system accuracy results are 98.1% GD40a Bloo Glucose Monitoring Buhist Tzu Chi within ±15mg/L & ±15% in the neonatal testing in Neonatal Perio General Hospital set. Results within Consensus Error Gri zones A Taipei Branch an B is 100%. (BTCGHTB IRB No. 00-IRB-006-FS) 26 Attestation of Conformity for FORA Oct 2013 DEKRA Certification DEKRA Certification B.V. eclares that the above Attestatio DM10, DM20, DM30, DM40 an GD50 The B.V. mentione proucts of FORACARE SUISSE AG fulfil n of Bloo Glucose Monitoring Netherlan s (No AoC01) the minimum system accuracy performance criteria accoring to EN ISO 15197:2013, section 6.3.3a. Conformit y This eclaration is base on a review of which the result is reporte in letter BLM/ FORA GD20 - Comparison of glucose Sep 2013 Dr. R. Frie Results fell within ±4.08% (average) at glucose level meters with heparinize whole bloo of mmol/l. Results fell within ±5.18% (average) at glucose level of mmol/l. Rev Apr V8 Page 6 of 9

7 List 28 FORA COMFORT pro GD40 - Sep 2013 Dr. R. Frie Results fell within ±2.53% (average) at glucose level of mmol/l. Results fell within ±10.56% heparinize whole bloo (average) at glucose level of mmol/l. 29 FORA COMFORT lux GD50 - Sep 2013 Dr. R. Frie Results fell within ±6.97% (average) at glucose level of mmol/l. Results fell within ±8.26% heparinize whole bloo (average) at glucose level of mmol/l. 30 FORA Diamon MINI DM30 - Jul 2013 Dr. R. Frie Results fell within ±0.19 mmol/l (average) at glucose level of 4.01 mmol/l. Results fell within heparinize whole bloo ±0.29 mmol/l (average) at glucose level of 3.99 mmol/l. 31 Performance Evaluation an Jul 2013 Report for FORA COMFORT pro GD40 Bloo Glucose Monitoring 15197: % results fell within ±15% at glucose levels of 100 mg/l or above. 100% results fell within ±15 mg/l at glucose levels below 100 mg/l. 32 Performance Evaluation an Mar 2013 Report for FORA COMFORT Basic G20 Bloo Glucose Monitoring ISO/DIS 15197: % results fell within ±15% at glucose levels of 100 mg/l or above. 100% results fell within ±15 mg/l at glucose levels Rev Apr V8 Page 7 of 9

8 List below 100 mg/l. 33 Evaluation of system accuracy of FORA Jan 2013 COMFORT plus voice V30 bloo glucose monitoring system ISO/DIS 15197: % results fell within ±15% at glucose levels of 100 mg/l or above. 100% results fell within ±15 mg/l at glucose levels below 100 mg/l. 34 Evaluation of system accuracy of FORA Jan 2013 Dr. Tomáš Zima Diamon PRIMA bloo glucose Czech Reference ISO/DIS 15197: % results fell within ±15% monitoring system of the at glucose levels of 5.56 mmol/l or above. 98.6% Ministry of Health results fell within ±0.83 mmol/l at glucose levels for below 5.56 mmol/l. Chemistry 35 Evaluation of system accuracy of FORA Jan 2013 Dr. Tomáš Zima Diamon MINI bloo glucose Czech Reference ISO/DIS 15197: % results fell within ±15% monitoring system of the at glucose levels of 5.56 mmol/l or above. 100% Ministry of Health results fell within ±0.83 mmol/l at glucose levels for below 5.56 mmol/l. Chemistry 36 FORA COMFORT pro GD40 - Dec 2012 Dr. R. Frie Results fell within ±7.19% (average) at glucose level of mmol/l. Results fell within ±0.26 mmol/l heparinize whole bloo (average) at glucose level of 5.07 mmol/l. Rev Apr V8 Page 8 of 9

9 List 37 FORA Diamon MINI DM30 - Dec 2012 Dr. R. Frie Results fell within ±13.28% (average) at glucose level of mmol/l. Results fell within ±0.56 heparinize whole bloo mmol/l (average) at glucose level of 5.07 mmol/l. 38 Comparison of FORA COMFORT pro Nov 2011 GD40 bloo glucose monitoring system ISO/DIS 15197:2011. with a hexokinase metho 39 Assessment of the reliability of FORA Aug 2011 Dr. Joëlle Gouable Excellent repeatability an reproucibility, an met COMFORT avance G31b bloo glucose France Centre Hospitalier accuracy requirements. This meter is in agreement monitoring system Lyon su with all the acceptance criteria of the ANSM. Rev Apr V8 Page 9 of 9