Roche Accu-Chek Performa
Device Name:
Accu-Chek Performa
Manufacturer:
Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Australia
Device Manual:
Click here to download the Device Manual
Description:
The Roche Accu-Chek Performa is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
The technology used in the Roche Accu-Chek Performa, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in eight clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BG TÜV Rheinland Nederland General use Unpublished internal data
BG MDR Criteria Self-measurement and professional use Published evidence
Consumer BodyYear(s)LevelComment
BG Choice (Australia) Latest: 2019 A
BG Amazon Best Sellers (US) Latest: 2019 B (3.6 / 5)
Validation Publications:

Robinson CS, Sharp P. Tighter accuracy standards within point-of-care blood glucose monitoring: how six commonly used systems compare. J Diabetes Sci Technol. 2012 May 1;6(3):547-54. doi: 10.1177/193229681200600309. PMID: 22768885.

15197:2003 - Pass General population

CLSI:2002 - Pass General population

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 (Note: Maltose dependent test strip)

15197:2013 - Pass General population (Note: Maltose dependent test strip)

15197:2003 - Pass General population (Note: Maltose independent test strip)

15197:2013 - Pass General population (Note: Maltose independent test strip)

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

Parwaiz M, Lunt H, Florkowski CM, Logan FJ, Irons L, Perwick C, Frampton CM, Moore MP. Assessment of glucose meter performance at the antenatal diabetes clinic: exploration of patient-related and pre-analytical factors. Ann Clin Biochem. 2014 Jan 5;51(Pt 1):47-53. Epub: 2013 Sep 3. doi: 10.1177/0004563213487893. PMID: 24003257.

15197:2013 - Pass General population

Huang TY, Chang HW, Tsao MF, Chuang SM, Ni CC, Sue JW, Lin HC, Hsu CT. Evaluation of accuracy of FAD-GDH- and mutant Q-GDH-based blood glucose monitors in multi-patient populations. Clin Chim Acta. 2014 Jun 10;433:28-33. Epub: 2014 Mar 5. doi: 10.1016/j.cca.2014.02.023. PMID: 24613515.

15197:2013 - Pass General population

Wide range of ages and diabetic conditions.

Freckmann G, Baumstark A, Jendrike N, Rittmeyer D, Pleus S, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in the Hands of Intended Users and Trained Personnel Based on ISO 15197 Requirements. Diabetes Technol Ther. 2017 Apr;19(4):246-54. Epub: 2017 Feb 22. doi: 10.1089/dia.2016.0341. PMID: 28225633.

15197:2013 General population (Note: Results not in Abstract)

Chen H, Yao Q, Dong Y, Tang Z, Li R, Cai B, Wang R, Chen Q. The accuracy evaluation of four blood glucose monitoring systems according to ISO 15197:2003 and ISO 15197:2013 criteria. Prim Care Diabetes. 2019 Jun;13(3):252-258. Epub: 2019 Feb 13. doi: 10.1016/j.pcd.2018.12.010. PMID: 30770203.

15197:2003 - Pass General population

15197:2013 - Pass General population

SKUP. Report from the evaluation SKUP/2011/93: Accu-Chek Performa (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2011. 49 p. Available from: skup.org.

15197:2003 - Pass General population

Relevant Publications:

Perera NJ, Molyneaux L, Constantino MI, McGill M, Yue DK, Twigg SM, Ross GP. Suboptimal performance of blood glucose meters in an antenatal diabetes clinic. Diabetes Care. 2011 Feb;34(2):335-337. Epub: 2011 Jan 7. doi: 10.2337/dc10-1457. PMID: 21216849. Available from: PMC3024344.

The publication evaluates the performance of the Roche Accu-Chek Performa, though not in a formal validation.

Thompson H, Chan H, Logan FJ, Heenan HF, Taylor L, Murray C, Florkowski CM, Frampton CM, Lunt H. A glucose meter evaluation co-designed with both health professional and consumer input. NZ Med J. 2013 Nov 22;126(1386):90-7. doi: .. PMID: 24316996.

Measurements from the Roche Accu-Chek Performa are compared to those from the i-Sens CareSens N POP, though not in a formal validation.

Ceriotti F, Kaczmarek E, Guerra E, Mastrantonio F, Lucarelli F, Valgimigli F, Mosca A. Comparative performance assessment of point-of-care testing devices for measuring glucose and ketones at the patient bedside. J Diabetes Sci Technol. 2015 Mar;9(2):268-77. Epub: 2014 Dec 17. doi: 10.1177/1932296814563351. PMID: 25519295. Available from: PMC4604596.

The publication evaluates the performance of the Roche Accu-Chek Performa, though not in a formal validation.

The interferences assessed included acetoacetate, acetaminophen, ascorbic acid, galactose, maltose, uric acid, and sodium. The accuracy of Accu-Chek glucose measurements was affected by haematocrit, by ascorbic acid, and significantly by galactose.

Demircik F, Ramljak S, Hermanns I, Pfützner A, Pfützner A. Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices J Diabetes Sci Technol. 2015 Mar;9(2):262-267. Epub: 2014 Dec 30. doi: 10.1177/1932296814565790. PMID: 25549636. Available from: PMC4604595.

Good accuracy but potential haematocrit influence.

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