i-Sens CareSens N POP

Device Name:

CareSens N POP

Manufacturer:

i-Sens Inc., 43 Banpo-daero 28-gil, Seocho-gu, Seoul 06646, REPUBLIC of KOREA.

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 i-Sens CareSens N POP is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-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 i-Sens CareSens N POP, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★ Recommendation	Recent clinical validation; recent protocol
BG	TÜV Rheinland Nederland	General use	Unpublished internal data
BG	MDR Criteria	Self-measurement and professional use	Published evidence

	Consumer Body	Year(s)	Level	Comment
BG	Choice (Australia)	Latest: 2019	A

Validation Publications:

Link M, Pleus S, Schmid C, Freckmann G, Baumstark A, Stolberg E, Haug C. Accuracy Evaluation of Three Systems for Self-monitoring of Blood Glucose With Three Different Test Strip Lots Following ISO 15197. J Diabetes Sci Technol. 2014 Mar;8(2):422-4. Epub: 2014 Mar 24. doi: 10.1177/1932296813518859. PMID: 24876597. Available from: PMC4455421.

15197:2003 - Pass General population

15197:2013 - Pass General population

Relevant Publications:

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