Pic Solution Pic GlucoTest

Device Name:

Pic GlucoTest

Manufacturer:

OBL: Pikdare S.r.l., Via Saldarini Catelli 10, 22070 Casnate con Bernate, ITALY.

OEM: SD Biosensor, C 4&5 Floor - Digital Empire Building 16, Deogyeong Dareo 1556beon gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC of KOREA.

Measuring functions:

Blood glucose

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Pic Solution Pic GlucoTest 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 taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Pic Solution Pic GlucoTest, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in three clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★★ Recommendation	Recent clinical validation; recent protocol; multiple clinical validations
BG	MDR Criteria	Self-measurement	Published evidence

Validation Publications:

Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.

15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot.)

Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.

15197:2013 - Pass General population