Table 5 Usability Assessment (n = 708)

 Did the study participant read/use the Instructions for Use (IFU)?

4

 If yes, was the Instructions for Use (IFU) read before the test?

38

 Was it referred to during the test process?

4

 Did the study participant wash and dry their hands as instructed in the Instructions for Use (IFU)?

374

 Was it difficult for the study participant to remove the test device from the pouch?

616

 Was the study participant able to remove the cap of Bottle 1?

7

 Did the study participant twist the tip of the lancet off?

2

 Did the study participant rub his/her finger correctly (up and down/vertical motion)?^a

79

 Was the study participant able to lance his/her finger correctly?^a

56

 Was the study participant able to form a blood droplet?

80

 Was the study participant able to get the blood droplet to fall into Bottle 1?^a

133

 Was the study participant able to twist the cap onto Bottle 1?

9

 Did the study participant apply bandage?

61

 Did the study participant shake Bottle 1, four (4) times?^a

78

 Did the study participant pour all the liquid from Bottle 1 into test device?^a

19

 Did participant wait until liquid from Bottle 1 disappeared before adding liquid from Bottle 2 into device?^a

14

 Did the study participant shake Bottle 2, four (4) times?^a

79

 Did the study participant pour the liquid from Bottle 2 into test device?^a

7

 Did participant wait until liquid from Bottle 2 disappeared before adding liquid from Bottle 3 into device?^a

13

 Did the study participant shake Bottle 3, four (4) times?^a

69

 Did the study participant pour the liquid from Bottle 3 into device and wait until liquid disappeared?^a

19

 Did the participant quit the process at any point?

701

 Did the participant perform the steps out of the order?^a

632

 Did the participant miss any step and continued the process despite a missed or incorrect step?