Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2915](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2915) → QZA — Body Temperature Sensing Software

# QZA · Body Temperature Sensing Software

_General Hospital · 21 CFR 880.2915 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QZA

## Overview

- **Product Code:** QZA
- **Device Name:** Body Temperature Sensing Software
- **Regulation:** [21 CFR 880.2915](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2915)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

Body temperature sensing software is a software device used for the determination of human body temperature by means of analyzing input sensor data. The Body Temperature Software (BTS) App is a software-only mobile medical application intended for over-the-counter (OTC) use with compatible mobile computing platforms that includes a general purpose infrared sensor for the intermittent determination of human body temperature on people of all ages.

## Classification Rationale

Class II (special controls). The device is classified under 21 CFR 880.2915.

## Special Controls

In combination with the general controls of the FD&C Act. the body temperature sensing software is subject to the following special controls:

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243778](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QZA/K243778.md) | Body Temperature Software (BTS) | Fitbit, LLC | Feb 13, 2025 | SESE |
| [DEN230050](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QZA/DEN230050.md) | Body Temperature Software (BTS) | Fitbit, LLC | Dec 15, 2023 | DENG |

## Top Applicants

- Fitbit, LLC — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QZA](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/QZA)

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