Evaluation of IFU for Nova Allegro System
Research type
Research Study
Full title
An evaluation of the comprehensibility and clarity of instructions for use (IFU) for a new testing device (Allegro Analyser) used to measure glucose, ketones and cholesterol in capillary and venous blood and for quantitative determination of albumin and creatinine in urine.
IRAS ID
233376
Contact name
Maurice O'Kane
Contact email
Sponsor organisation
Nova Biomedical
Clinicaltrials.gov Identifier
17/LO/1505, London-Brent
Duration of Study in the UK
0 years, 6 months, 14 days
Research summary
The Nova Allegro System is currently marketed and available for professional healthcare use in the EU market under a self-declared CE mark. This study evaluates the product labeling for the Nova Allegro System design prior to CE self-testing market approval in the EU.
The Nova Allegro System is equipped with 3 different Test Cartridges designed to measure capillary whole blood obtained from a fingerstick or urine specimens obtained from a cup. The Nova Allegro System is intended for invitro diagnostic use by health care professionals for the quantitative determination of the percent of Haemoglobin A1c (HbA1c), Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, and Triglycerides in capillary whole blood obtained from the fingertip and venous whole blood. It is also intended for quantitative determination of Albumin and Creatinine in urine.
This study will evaluate the comprehensibility and clarity of instructions for use of the Nova Allegro System product labeling in the hands of the intended user and will assess the ability of the intended user to perform, view and understand the results presented on the analyzer.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1505
Date of REC Opinion
13 Sep 2017
REC opinion
Further Information Favourable Opinion