Abbott FreeStyle Optium Neo H

Device Name:

Freestyle Optium Neo H

Manufacturer:

Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.

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 Abbott FreeStyle Optium Neo H 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 taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Abbott FreeStyle Optium Neo H, 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. It has also been assessed, in a specific population, according to a non-standard protocol.

Recommendations:

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

Validation Publications:

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

Baines CR, Cooper PD, O'Rourke GA, Miller C. Evaluation of the Abbot FreeStyle Optium Neo H blood glucose meter in the hyperbaric oxygen environment. Diving Hyperb Med. 2020 Jun 30;50(2):144-151. doi: 10.28920/dhm502144-151. PMID: 32557416. Available from: PMC7481119.

Ad Hoc protocol Non-diabetic hyperbaric subjects, aged 35 to 55 years (n=10)

The FreeStyle Optium™ Neo H glucometer is safe to use and provides a reliable measurement of blood glucose in a hyperbaric oxygen treatment environment.