One study has been performed to demonstrate the clinical performance of the Pivot breath sensor. That study included 70 participants and compared the performance of the Pivot breath sensor to the Bedfont Micro+™ Smokerlyzer ®. Each participant did a breath sample on the Pivot breath sensor, and then a breath sample on the Bedfont Micro+™ Smokerlyzer ® three to five minutes later.
The overall color category agreement result of the study was 87% (61/70). That is to say, the color category of the breath sample performed on the Pivot breath sensor was the same as the color category of the breath sample performed shortly after on the Bedfont Micro+™ Smokerlyzer® 91% of the time. The agreement for each color category over the 0-100 ppm operating range of the device is shown below