Body Temperature Software (BTS)

The Body Temperature Software (BTS) is an over-the-counter mobile medical app that uses a smartphone's infrared sensor to measure human body temperature non-contact by performing a forehead sweep. It converts temporal artery skin temperature readings into an estimated body (rectal) temperature and is intended for users 18 years and older to measure temperature for themselves or others.

The subject device replaces specific numerical pre-measurement threshold values with binary flags (sensor too warm/cold, skin too warm/cold, difference too high) that gate temperature measurement eligibility. The sensor ambient temperature range is now hardware-dependent rather than a fixed 15°C-35°C range. Compatible devices expand beyond just Pixel 8 Pro to other Pixel smartphones meeting Android 14+ requirements. All other specifications remain identical: ±0.3°C accuracy, 94.1°F-109.4°F measurement range, 0.1°C resolution, temporal-to-rectal temperature conversion algorithm.

ISO 80601-2-56 (laboratory accuracy validation), ISO 14971 (risk management).

The device is substantially equivalent because the modifications—converting scalar threshold checks into binary qualification flags and making sensor ambient temperature hardware-dependent—do not alter the indications for use, core algorithm, user interface, or measurement principle. Validation testing and software verification confirm the binary flags function identically to the predicate's proximity checks in ensuring measurement is only performed under appropriate conditions. Expanded compatible hardware and validated accuracy testing at hardware-specific temperature ranges show no new safety or effectiveness questions arise from these changes.