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Roche Accu-Chek Inform II
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
Device Manual:
Description:
The Roche Accu-Chek Inform II is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:
The technology used in the Roche Accu-Chek Inform II, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in seven clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
MDR Criteria Self-measurement and professional use Published evidence
Validation Publications:

Gijzen K, Moolenaar DL, Weusten JJ, Pluim HJ, Demir AY. Is there a suitable point-of-care glucose meter for tight glycemic control? Evaluation of one home-use and four hospital-use meters in an intensive care unit. Clin Chem Lab Med. 2012 Nov;50(11):1985-92. PMID: 22718643.

15197:2003 - Pass General population

Mitsios JV, Ashby LA, Haverstick DM, Bruns DE, Scott MG. Analytic evaluation of a new glucose meter system in 15 different critical care settings. J Diabetes Sci Technol. 2013 Sep 1;7(5):1282-7. doi: 10.1177/193229681300700518. PMID: 24124955. Available from: PMC3876372.

CLSI:2013 - Pass Critically ill patients

Ba Y, Xu J, Yuan L, Zhu H, Yang Y, Lam MM, Zhang S, Xiao M, Xu J, Zhang R, Chen C. Assessment of the performance of blood glucose monitoring systems for monitoring dysglycaemia in neonatal patients. BMJ Paediatr Open. 2018 Oct 23;2(1):e000339. doi: 10.1136/bmjpo-2018-000339. PMID: 30397671. Available from: PMC6203032. eCollection 2018.

CLSI:2013 - Fail Neonates (Note: Meter is susceptible to interference by low concentrations of galactose that could potentially influence the ability to detect hypoglycaemia.)

CMA:2016 Neonates

Kim HN, Moon KC, Yoon SY. Performance evaluation of three i-SENS glucometers using arterial blood samples compared with the YSI 2300 Glucose Analyzer. J Clin Lab Anal. 2020 Aug;34(8):e23356. Epub: 2020 May 19. doi: 10.1002/jcla23356. PMID: 32430994. Available from: PMC7439437.

15197:2013 - Pass General population (Note: Modified protocol: Fewer samples with low and high blood glucose concentrations than recommended. One reagent system lot.)

Nichols JH, Brandler ES, Fantz CR, Fisher K, Goodman MD, Headden G, Hoppensteadt D, Matika R, Peacock WF, Rodrigo J, Sch├╝tzenmeister A, Swanson JR, Canada-Vilalta C, Miles G, Tran N. A Multicenter Evaluation of a Point-of-Care Blood Glucose Meter System in Critically Ill Patients. J Appl Lab Med. 2021 Jul 7;6(4):820-833. doi: 10.1093/jalm/jfab005. PMID: 33837390.

FDA:2020P - Pass Neonates (0-28 days), arterial samples (n=100)

FDA:2020P - Pass Neonates (0-28 days), heel-stick samples (n=100)

FDA:2020P - Pass Infants to Adults (29 days to over 22 years), arterial samples (n=376)

FDA:2020P - Pass Infants to Adults (29 days to over 22 years), venous samples (n=375)

Relevant Publications:

Joseph JI. Analysis: New point-of-care blood glucose monitoring system for the hospital demonstrates satisfactory analytical accuracy using blood from critically ill patients--an important step toward improved blood glucose control in the hospital. J Diabetes Sci Technol. 2013 Sep 1;7(5):1288-93. doi: 10.1177/193229681300700519. PMID: 24124956. Available from: PMC3876373.

The publication is a letter or correspondence in which the Roche Accu-Chek Inform II is referenced.

Jeong TD, Cho EJ, Ko DH, Lee W, Chun S, Hong KS, Min WK. Large-scale performance evaluation of Accu-Chek inform II point-of-care glucose meters. Scand J Clin Lab Invest. 2016 Dec;76(8):657-63. Epub: 2016 Oct 14. doi: 10.1080/00365513.2016.1233575. PMID: 27739331.

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

Kim HN, Yoon SY. Comparative study of i-SENS glucometers in neonates using capillary blood samples. Clin Chem Lab Med. 2021 Jan 22;59(6):1133-1141. doi: 10.1515/cclm-2020-1367. PMID: 33915605.

15197:2013 - Pass Neonates