| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
| BG | FDA (US) | 510(k) | 510(k) K083628 |
| BG | Institute of Health Economics (CA) | General use | No evidence provided |
| BG | MDR Criteria | Self-measurement | Published evidence |
Legend: F FDA 510(k)
Jendrike N, Baumstark A, Kamecke U, Haug C, Freckmann G. ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy. J Diabetes Sci Technol. 2017 Nov;11(6):1275-6. Epub: 2017 Aug 29. doi: 10.1177/1932296817727550. PMID: 28849677. Available from: PMC5951056. No abstract available.
15197:2013 - Pass General population
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Roche Accu-Chek Advantage (V1)
Ho HT, Yeung WK, Young BW. Evaluation of "point of care" devices in the measurement of low blood glucose in neonatal practice. Arch Dis Child Fetal Neonatal Ed. 2004 Jul;89(4):F356-359. doi: 10.1136/adc.2003.033548. PMID: 15210675. Available from: PMC1721720.
ADA:1994 - Fail Neonates (n = 57) (Note: Error < 10 %: 20.0% )
CLSI:1994 - Fail Neonates (n = 57) (Note: Error ≤ 0.83 mmol/L: 81.5% (< 95 %))
Thomas LE, Kane MP, Bakst G, Busch RS, Hamilton RA, Abelseth JM. A glucose meter accuracy and precision comparison: the FreeStyle Flash Versus the Accu-Chek Advantage, Accu-Chek Compact Plus, Ascensia Contour, and the BD Logic. Diabetes Technol Ther. 2008 Apr;10(2):102-110. doi: 10.1089/dia.2007.0244. PMID: 18260773.
Ad Hoc protocol General population
Roche Accu-Chek Aviva
Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.
15197:2003 - Pass General population
de Mol P, Krabbe HG, de Vries ST, Fokkert MJ, Dikkeschei BD, Rienks R, Bilo KM, Bilo HJ. Accuracy of handheld blood glucose meters at high altitude. PLoS One. 2010 Nov 12;5(11):e15485. doi: 10.1371/journal.pone.0015485. PMID: 21103399.
Ad Hoc protocol - Pass High Altitude (Note: Simulated altitude in hypobarbic chamber)
Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfützner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. Epub: 2011 Dec 16. doi: 10.1089/dia.2011.0170. PMID: 22176154.
15197:2003 - Pass General population
15197:2013 - Fail General population
Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1076-86. doi: 10.1177/193229681200600511. PMID: 23063033. Available from: PMC3570841.
15197:2003 - Pass General population (Note: 4 test-strip lots; all 4 within requirements)
Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.
15197:2003 - Pass General population
15197:2013 - Pass General population
Pfützner A, Mitri M, Musholt PB, Sachsenheimer D, Borchert M, Yap A, Forst T. Clinical assessment of the accuracy of blood glucose measurement devices. Curr Med Res Opin. 2012 Apr;28(4):525-31. Epub: 2012 Mar 21. doi: 10.1185/03007995.2012.673479. PMID: 22435798.
15197:2003 - Pass General population
Zueger T, Schuler V, Stettler C, Diem P, Christ ER. Assessment of three frequently used blood glucose monitoring devices in clinical routine. Swiss Med Wkly. 2012 Jul 12;142:w13631. doi: 10.4414/smw.2012.13631. PMID: 22791566. eCollection 2012.
15197:2003 - Pass General population (Note: Reference device: HemoCue Glucose 201+)
Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.
15197:2003 - Fail Using insufficient blood samples (n=31)
Halldorsdottir S, Warchal-Windham ME, Wallace JF, Pardo S, Parkes JL, Simmons DA. Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1294-304. doi: 10.1177/193229681300700520. PMID: 24124957. Available from: PMC3876374.
Ad Hoc protocol General population
Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.
15197:2003 - Pass General population
15197:2013 - Pass General population
Pfützner A, Hengesbach C, Demircik F, Schipper C, Forst T, Musholt PB. Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria. Curr Med Res Opin. 2014 Feb;30(2):185-90. Epub: 2013 Nov 6. doi: 10.1185/03007995.2013.858617. PMID: 24156775.
15197:2003 - Pass General population
15197:2013 - Pass General population
Pleus S, Schmid C, Link M, Baumstark A, Haug C, Stolberg E, Freckmann G. Accuracy assessment of two novel systems for self-monitoring of blood glucose following ISO 15197:2013. J Diabetes Sci Technol. 2014 Jul;8(4):906-8. Epub: 2015 Ma5 25. doi: 10.1177/1932296814536030. PMID: 24876447. Available from: PMC4764206.
15197:2013 - Pass General population
Link M, Schmid C, Pleus S, Baumstark A, Rittmeyer D, Haug C, Freckmann G. System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method. J Diabetes Sci Technol. 2015 Apr 14;9(5):1041-50. doi: 10.1177/1932296815580161. PMID: 25872967. Available from: PMC4667333.
15197:2003 - Pass General population
15197:2013 - Pass General population (Note: HK Comparison (Manufacturer))
15197:2013 - Pass General population (Note: GOx Comparison (Alternative))
Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.
15197:2013 - Pass General population (Note: BLS-recorded measurements)
FDA:2016H - Pass General population (Note: BLS-recorded measurements)
15197:2013 - Fail General population (Note: Subject-recorded measurements)
FDA:2016H - Fail General population (Note: Subject-recorded measurements)
15197:2003 - Pass General population
SKUP Evaluations 2005/44, 2013/98
Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Högel J, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197. Diabetes Technol Ther. 2015 Sep;17(9):625-34. Epub: 2015 May 19. doi: 10.1089/dia.2015.0043. PMID: 26062008.
15197:2013 General population (Note: Results not in Abstract)
Sutheran HL, Reynolds T. Technical and clinical accuracy of three blood glucose meters: clinical impact assessment using error grid analysis and insulin sliding scales. J Clin Pathol. 2016 Oct;69(10):899-905. Epub: 2016 Feb 5. doi: 10.1136/jclinpath-2015-203339. PMID: 26850631.
15197:2003 General population
From the absract, it appears that an evaluation of the Abbott FreeStyle Lite, the Roche Accu-Chek Aviva and an unnamed third device was performed. Neither the protocol used nor the results are clear from the abstract.
Mancini A, Esposto G, Manfrini S, Rilli S, Tinti G, Carta G, Petrolati L, Vidali M, Barocci S. A Real-World Setting Study: Which Glucose Meter Could Be the Best for POCT Use? An Easy and Applicable Protocol During the Hospital Routine. J Diabetes Sci Technol. 2018 Sep;12(5):1053-1060. Epub: 2018 May 22. doi: 10.1177/1932296818774077. PMID: 29783898. Available from: PMC6134620.
SIBioC:2015 General population
Note: Results from this paper are not presented due to a number of inaccuracies.
Dunseath GJ, Bright D, Luzio SD. Comparative Accuracy Evaluation of a Blood Glucose Meter With Novel Hematocrit Correction Technology, With Three Currently Used Commercially Available Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2019 May;13(3):568-574. Epub: 2019 Jan 9. doi: 10.1177/1932296818821389. PMID: 30623673. Available from: PMC6501526.
15197:2013 - Pass General population (Note: Modified protocol: Single batch of test strips only. Some hematocrit associated bias noted.)
SKUP. Report from the evaluation SKUP/2005/44: Accu-Chek Aviva (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2005. 40 p. Available from: skup.org.
15197:2003 - Pass General population (Note: BLS-recorded measurements)
15197:2003 - Pass General population (Note: Subject-recorded measurements)
Results counted in Sølvik et al. 2015.
SKUP. Report from the evaluation SKUP/2013/98: Accu-Chek Aviva (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2013. 38 p. Available from: skup.org.
15197:2003 - Pass General population
Results counted in Sølvik et al. 2015.
SKUP. Report from the evaluation SKUP/2014/105: Accu-Chek Aviva (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2014. 55 p. Available from: skup.org.
15197:2013 - Pass General population (Note: BLS-recorded measurements)
15197:2013 - Pass General population (Note: Subject-recorded measurements)